| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04547410480665 | DR-XD 3000 HOLDER4343 E | A flat panel sensor holder used to mount a 17" x 17" flat panel sensor onto DR-XD 3000FX. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Flat panel sensor holder | |
| 2 | 04547410480658 | DR-XD 3000 HOLDER3543 E | A flat panel sensor holder used to mount a 14" x 17" flat panel sensor onto DR-XD 3000FX. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Flat panel sensor holder | |
| 3 | 04547410480641 | DR-XD 3000 HOLDER2530 E | A flat panel sensor holder used to mount a 10" x 12" flat panel sensor onto DR-XD 3000FX. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | Flat panel sensor holder | |
| 4 | 04547410478631 | DR-ID 1811 SE NON CE E | The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVOIII C35i | |
| 5 | 04547410467710 | DR-XD 3000 | The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, whi The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics.The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging.It is intended for use in procedures such as holangiography, endoscopic, urologic, orthopedic, neurologic, critical care, peripheral vascular, emergency room procedures.This device does not support cardiac procedures and is not intended for use in performing mammography. | OWB,JAA | Interventional Fluoroscopic X-Ray System,System, X-Ray, Fluoroscopic, Image-Intensified | 2 | FDR CROSS | |
| 6 | 04547410445466 | DR-ID 1811 SE E | The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel The DR-ID 1811SE, DR-ID 1812SE and DR-ID 1814SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVOIII C35i | |
| 7 | 04547410426915 | DR-ID 1802 SE E | The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect The DR-ID 1801SE and DR-ID 1802SE incorporate a GOS indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVOIII G43 | |
| 8 | 04547410425505 | DR-XD 1000 | The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in g The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purposeradiography for generating radiographic images of human anatomy, including adult, pediatric, andneonatal exams. The DR-XD 1000 is not intended for mammography applications. | IZL | System, x-ray, mobile | 2 | FDR AQRO | |
| 9 | 04547410361360 | DR-ID 1273 SE E | The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to ca The Wired/Wireless FDR ES (DR-ID1270) flat panel sensor system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. It is not intended for mammography, fluoroscopy, tomography, and angiography applications. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR ES C35 | |
| 10 | 04547410339161 | DR-XD 1000 | The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in g The DR-XD 1000 (FDR AQRO) is a digital mobile X-ray system intended for use in general purposeradiography for generating radiographic images of human anatomy, including adult, pediatric, andneonatal exams. The DR-XD 1000 is not intended for mammography applications. | IZL | System, x-ray, mobile | 2 | FDR AQRO | |
| 11 | 04547410242010 | COMP PLATE AXILLA 8X20 HA E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | Compression plate for axilla radiography | |
| 12 | 04547410309324 | DR-ID 1212 SE A E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVO II C43 | |
| 13 | 04547410302745 | COMP PLATE 18X24 S FS HA E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | 18x24 comfort paddle (FS Small) | |
| 14 | 04547410297843 | IR DUMMY CASSETTE FOR M MBL E | Before moving the vehicle, be sure to turn off the FCR PRIMA Tm and insert the d Before moving the vehicle, be sure to turn off the FCR PRIMA Tm and insert the dummy cassette. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Dummy Cassette (For Mobile) | |
| 15 | 04547410290899 | DR-ID 1200 AP-SE CBL E | A cable used for connecting the flat panel sensor and the optional access point. A cable used for connecting the flat panel sensor and the optional access point. This cable is used for wired communication if wireless communication is not available. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | SE communication cable | |
| 16 | 04547410241990 | COMP PLATE SPOT 9X9 HA E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | Rectangular spot compression plate | |
| 17 | 04547410288971 | DR-ID 1200 MP E | A device supplying power to the flat panel sensor and connecting between theflat A device supplying power to the flat panel sensor and connecting between theflat panel sensor and the control cabinet. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Power supply unit* | |
| 18 | 04547410288957 | DR-ID 1212 SE E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVO II C43 | |
| 19 | 04547410270129 | COMP PLATE 18X24 HIGH HA A E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | 18x24 Compression plate (High) | |
| 20 | 04547410259056 | DR-ID 600/601 MP A E | Supplies the power to the flat panel sensor and connects the flat panel sensor a Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 600MP | |
| 21 | 04547410250459 | CR-IR 359 | The FCR XL-2/FCR Aspire CRm (CR-IR 359) is equipment designed to read X-ray imag The FCR XL-2/FCR Aspire CRm (CR-IR 359) is equipment designed to read X-ray image information recorded on an imaging plate (IP). | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FCR XL-2 | |
| 22 | 04547410245042 | DR-ID 612 SE E | The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. T The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode). | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR D-EVO plus C43i | |
| 23 | 04547410242201 | COMP PLATE LATERAL BIOPSY HA E | Compression plate for Lateral Biopsy | MUE | Full field digital,system,x-ray,mammographic | 2 | Lateral compression plate | |
| 24 | 04547410242034 | COMP PLATE MAG1.8 16X20 HA E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | Compression plate for magnifications | |
| 25 | 04547410222104 | IR ADAPTER FOR IP 15X30CM E | 47410-22210 | Inserting the Fuji Imaging Plate ST-VI 15cmx30cm into the adapter to insert it i Inserting the Fuji Imaging Plate ST-VI 15cmx30cm into the adapter to insert it into 35cmx43cm cassette makes image reading in the Fuji Computed Radiography possible. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | 15X30 IP ADAPTER |
| 26 | 04547410215373 | IR DUMMY CASSETTE FOR MBL E | Before moving the vehicle, be sure to turn off the FCR PRIMA T and insert the du Before moving the vehicle, be sure to turn off the FCR PRIMA T and insert the dummy cassette. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Dummy Cassette (For Mobile) | |
| 27 | 04547410211368 | LATERAL NEEDLE STOPPER E E | Adjust the depth that the needle is inserted. The slide stopper differs for each Adjust the depth that the needle is inserted. The slide stopper differs for each needle. Use a slide stopper that suits each type of needle being used. | MUE | Full field digital,system,x-ray,mammographic | 2 | Slide stopper E | |
| 28 | 04547410189988 | CR-IR 391RU | The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image informa The FCR PRIMA II (CR-IR 391RU) is equipment designed to read X-ray image information recorded on an imaging plate (IP). | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FCR PRIMA II | |
| 29 | 04547410181777 | NEEDLE HOLDER EN E | Holder to fix the Biopsy Needle | MUE | Full field digital,system,x-ray,mammographic | 2 | Needle holder E | |
| 30 | 04547410178678 | DR-ID 600/601 MP E | Supplies the power to the flat panel sensor and connects the flat panel sensor a Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 600MP | |
| 31 | 04547410143140 | NEEDLE GUIDE C 18G E | This guide is used for the CNB and FNA type needles and the hook wire. | MUE | Full field digital,system,x-ray,mammographic | 2 | Needle guide C-L/C-S (18G) | |
| 32 | 04547410143119 | NEEDLE HOLDER M 8G E | Holder to fix the Biopsy Needle | MUE | Full field digital,system,x-ray,mammographic | 2 | Needle holder M8 | |
| 33 | 04547410091946 | AXILLA PAD LEFT E | Axilla pad help relieve discomfort of the patient when she is positioned for exposure. | MUE | Full field digital,system,x-ray,mammographic | 2 | Axilla pad L | |
| 34 | 04547410457704 | DR-ID 800 IU DV3 E | DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR D-EVO Mobile Compo | |
| 35 | 04547410436716 | DR-ID 1212 SE W SDK E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 1212SE | |
| 36 | 04547410436709 | DR-ID 1211 SE W SDK E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 1211SE | |
| 37 | 04547410359886 | COMP PLATE 24X30 HIGH HA USA E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | 24x30 Compression plate (High) | |
| 38 | 04547410355420 | DR1270 SE BATTERY E | A battery pack for the flat panel sensor. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR ES Battery Pack | |
| 39 | 04547410333527 | DR-ID800CL | The Console is a workstation intended to associate digital (for DR) images with The Console is a workstation intended to associate digital (for DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. | LLZ | System, image processing, radiological | 2 | DR-ID800CL | |
| 40 | 04547410308532 | DR-ID 1212 SE W E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 1212SE | |
| 41 | 04547410308525 | DR-ID 1211 SE W E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 1211SE | |
| 42 | 04547410308402 | DR-ID 800 IU DV2 E | DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting DR-ID 800 (FDR D-EVO Mobile Compo) is digital radiography equipment for mounting on the Mobile Cart and employs an indirect-conversion FPD. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR D-EVO Mobile Compo | |
| 43 | 04547410308211 | DR-ID 1201 SE A E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVO II G35 | |
| 44 | 04547410288995 | DR-ID 1200 MC SOFT E | A personal computer used for controlling the flat panel sensor and performing im A personal computer used for controlling the flat panel sensor and performing image processing. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | DR-ID 1200MC | |
| 45 | 04547410288803 | DR-ID 1201 SE E | The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 12 The DR-ID 1201SE and DR-ID 1202SE incorporate a GOS indirect panel. The DR-ID 1211SE, DR-ID 1212SE and DR-ID 1213SE incorporate a CsI indirect panel. The indirect-conversion flat panel sensor is a device which acquires a general radiograph. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | D-EVO II G35 | |
| 46 | 04547410270112 | COMP PLATE 18X24 LOW HA A E | Compression plate | MUE | Full field digital,system,x-ray,mammographic | 2 | 18x24 Compression plate (Low) | |
| 47 | 04547410249965 | DR 3500 TOMO FACE GUARD E | Face Guard | MUE | Full field digital,system,x-ray,mammographic | 2 | Face Guard T | |
| 48 | 04547410235944 | DR-ID 601 SE A E | The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. T The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode). | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FDR D-EVO G35i | |
| 49 | 04547410220667 | CR-IR 363 | The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Dig The FUJI Computed Radiography System FCR ClearView CS Plus/CSm Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FCR ClearView CS Plus | |
| 50 | 04547410220629 | CR-IR 362 | The FUJI Computed Radiography System FCR XG 5000 Plus performs Digital Radiograp The FUJI Computed Radiography System FCR XG 5000 Plus performs Digital Radiography by using an Imaging Plate (IP) as the X-ray detection device. | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FCR XG5000 Plus |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03701440100172 | 62833765 | ArtPiX Mobile EZ2GO | THALES AVS FRANCE SAS | ||
| 2 | 03701440100035 | 63111976 | Duet DRF | THALES AVS FRANCE SAS | ||
| 3 | 00935712300004 | Rover | MXU-RV01 | The device is designed to perform radiographic x-ray examinations on pediatric a The device is designed to perform radiographic x-ray examinations on pediatric and adult patients, in all patient treatment areas | Micro-X | MICRO-X LIMITED |
| 4 | E31584682012000 | 8468201200 | Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items | PantOs 16 xp | FONA SRL | |
| 5 | E31584682005000 | 8468200500 | Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including pat Analog Panoramic and Cephalometric X-Ray Unit with 10x8" cassette, including patient positioning items | PantOs 16 xp Ceph | FONA SRL | |
| 6 | E31584682003000 | 8468200300 | Digital Panoramic X-Ray Unit, including patient positioning items | PantOs DG xp | FONA SRL | |
| 7 | E31584682001000 | 8468200100 | Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items | PantOs 16 xp | FONA SRL | |
| 8 | 00884838090705 | 712035 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 9 | 00884838090699 | 712034 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 10 | 00884838086753 | 4598-013-7583. | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate small | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 11 | 00884838085695 | 9890-010-83904 | 712228 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 12 | 00884838085688 | 9890-010-83904 | 712227 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 13 | 00884838085671 | 9890-010-83904 | 712226 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 14 | 00884838084636 | 4598-012-4298. | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 15 | 00884838074705 | 9897-010-02681 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 16 | 00884838074538 | 9897-010-01041 | 712090 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | ProGrade | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 17 | 00884838074521 | 9890-010-83904 | 712033 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 18 | 00884838074514 | 9890-010-83904 | 712032 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 19 | 00884838074279 | 9890-010-87752 | 706050 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Wireless Portable Detector | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 20 | 00884838065321 | 9890-010-83904 | 712031 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 21 | 00884838065239 | 9897-010-01041 | 712090 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | ProGrade | PHILIPS MEDICAL SYSTEMS DMC GMBH |
| 22 | 00884838065222 | 9897-010-00834 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 23 | 00884838065215 | 9897-010-00843 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate small | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
| 24 | 00884838064751 | 712214 | 712214 | The DuraDiagnost is intended for use in generating radiographic images of human The DuraDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. | DuraDiagnost | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
| 25 | 00884838064737 | 989701001012 | 712213 | The DuraDiagnost Compact is intended for use in generating radiographic images o The DuraDiagnost Compact is intended for use in generating radiographic images of human anatomy by qualified/trained doctor or technician. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications. | DuraDiagnost Compact | PHILIPS HEALTHCARE (SUZHOU) CO., LTD. |
| 26 | 00869126000444 | Edge Air | Digital X-Ray flat panel detector used to acquire radiographic images of human a Digital X-Ray flat panel detector used to acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. | Edge Air | OSKO, INC. | |
| 27 | 00869126000437 | Edge | Digital Flat Panel X-Ray Detector used to generate images of any part of the bod Digital Flat Panel X-Ray Detector used to generate images of any part of the body. The system consists of a scintillator directly coupled to an a-Si TFT sensor. The system generates high-resolution and high-sensitive digital images. | Edge | OSKO, INC. | |
| 28 | 00866389000198 | CAS1417 | The Radlink Cassette is a digital imaging cassette that holds a flat panel detec The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation. This model is designed for 14"x17" plates. | Radlink Cassette | RADLINK, INC. | |
| 29 | 00866389000181 | CAS1012 | The Radlink Cassette is a digital imaging cassette that holds a flat panel detec The Radlink Cassette is a digital imaging cassette that holds a flat panel detector during x-ray exposure and has a grid to absorb scattered radiation.This model is designed for 10"x12" plates. | Radlink Cassette | RADLINK, INC. | |
| 30 | 00866389000150 | CR201-1 | The Radlink CR Pro system is a computed radiography system designed for all prim The Radlink CR Pro system is a computed radiography system designed for all primary diagnostic radiology applications. It is fully automatic and accepts a variety of cassette sizes.The 16-bit sealed fiber-optic laser technology allows images to be erased after each use, prolonging cassette life. The system includes the Radlink PACS that is DICOM compatible with any other PACS/EMR brand. The software provides image quality control and post-processing functions and enables distribution and routing of DICOM images throughout a healthcare network. Existing patient information can be queried by syncing to any EMR/HIS/RIS modality worklist. | Radlink CR Pro 2200 | RADLINK, INC. | |
| 31 | 00866389000143 | DR2200 | The Radlink DR Pro system is a digital radiography system with a digital flat pa The Radlink DR Pro system is a digital radiography system with a digital flat panel detector that captures images from any brand of X-ray generator and displays them on a touch screen monitor within four seconds. A local PACS is available to archive and manage images not only from the DR Pro, but also from other DICOM modalities such as X-ray, MRI, CT, and ultrasound. | Radlink DR Pro 2200 | RADLINK, INC. | |
| 32 | 00866389000112 | TABLET | The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic i The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit. | Radlink GPS Tablet 2200 | RADLINK, INC. | |
| 33 | 00866389000105 | GPS2200 | The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time f The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS and its Surgeon’s Checklist™ software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS consists of a computer system that uses two monitors . Pre-operative images can be viewed on the top monitor during surgery at the same time that intraoperative images are being viewed on the lower monitor. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which take approximately four seconds to appear on the lower GPS monitor. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the lower monitor of the GPS. | Radlink GPS 2200 | RADLINK, INC. | |
| 34 | 00864908000162 | GPS Trauma | The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time f The Radlink Galileo Positioning System™ (GPS) provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS and its Surgeon’s Checklist™ software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS consists of a computer system that uses one ultra-wide monitor. | Radlink GPS Trauma | RADLINK, INC. | |
| 35 | 00864908000148 | M STAND | The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charg The Radlink GPS Tablet/Monitor Stand functions as a mobile workstation and charger for the Radlink GPS Tablet with a secondary monitor. The Radlink GPS Tablet provides surgeons with real-time feedback on orthopedic implant component positioning. Together, the GPS Tablet and its Surgeon’s Checklist software offer easy-to-follow steps designed to address challenges such as component positioning, sizing, limb length and offset restoration. The Radlink GPS Tablet consists of a Tablet PC computer system that uses a touchscreen monitor & other image display accessories. Pre-operative images can be viewed on the GPS Tablet during surgery, which surgeons can use to reference against the intraoperative images captured during the procedure. For posterior approach THA procedures, a flat panel detector (DR panel) is used to capture intraoperative images, which takes approximately four seconds to appear on the GPS Tablet. For anterior approach THA procedures, C-Arm images are instantaneously transferred to the GPS Tablet using the Radlink Wireless C-Arm Kit. | Radlink GPS Tablet/Monitor Stand | RADLINK, INC. | |
| 36 | 00864908000131 | PH BRACKET | The PH GPS Bracket is comprised of Radlink proprietary software and hardware to The PH GPS Bracket is comprised of Radlink proprietary software and hardware to duplicate Radlink user interface onto Philips reference monitor of the MVS utilizing a switch box that shifts the video signal between Philips and Radlink on the reference monitor. Not only does Radlink solution expand the field of view of Philips C-Arms utilizing Pano function, but it also facilitates intra-operative image analysis by assisting surgeons to evaluate acetabular cup position, limb length discrepancy, and femoral offset during Total Hip Arthroplasty. The PH GPS Bracket comes with software features such as image stitching and Surgeon’s Checklist™ software that provides surgeons with real-time feedback on orthopedic implant component positioning. Pre-operative images can be viewed on the device during surgery, which surgeons can use to reference against the intra-operative images captured during the procedure. | Radlink PH GPS Bracket | RADLINK, INC. | |
| 37 | 00864908000124 | STAND | The Radlink GPS Tablet Stand functions as a mobile workstation and charger for t The Radlink GPS Tablet Stand functions as a mobile workstation and charger for the Radlink GPS Tablet and Wireless C-Arm Kit. The stand can be connected to a mains electricity source and charge both the GPS Tablet and WCA Kit simultaneously. Accessories for both devices can also be housed in the GPS Tablet Stand. | Radlink GPS Tablet Stand | RADLINK, INC. | |
| 38 | 00864908000100 | DRRETRO | The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into The Radlink DR Tablet Retrofit upgrades any existing portable x-ray machine into a mobile digital radiography system.It is a permanently mounted Tablet PC for image acquisition with built-in PACS and DICOM connectivity. Radlink Pro-Imaging Acquisition and Post-Processing Software are featured on the system as well. It comes with a Cesium wireless flat panel detector. | Radlink DR Tablet Retrofit | RADLINK, INC. | |
| 39 | 00860008321336 | TUXEDO INTRAORAL SENSOR | 6101AR Size 2 | This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator. | Tuxedo | TUXEDO IMAGING LLC |
| 40 | 00860008321329 | TUXEDO INTRAORAL SENSOR | 6100AR Size 1 | This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator. | Tuxedo | TUXEDO IMAGING LLC |
| 41 | 00860008321312 | TUXEDO INTRAORAL SENSOR | 6101A Size 2 | This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator. | Tuxedo | TUXEDO IMAGING LLC |
| 42 | 00860008321305 | TUXEDO INTRAORAL SENSOR | 6100A Size 1 | This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a This is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional. The Tuxedo sensor itself is a single piece comprised of the image capture components on one end, with a USB 2.0 plug on the other end. The sensor is designed to be used in conjunction with a disposable, single-use hygienic sheath as well as a positioning device to allow for proper alignment within the patient’s mouth. Images are acquired with the Tuxedo sensor by plugging it into a USB port and properly placing it in the patient’s mouth, while an operator exposes radiation toward the sensor from an approved intraoral x-ray generator. | Tuxedo | TUXEDO IMAGING LLC |
| 43 | 00858846007222 | CMDR.TW.1202.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 44 | 00858846007215 | CMDR.PE.1202.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 45 | 00858846007208 | CMDR.PE.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 46 | 00858846007192 | CMDR.TW.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 47 | 00858846007185 | CMDR.PE.100.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 48 | 00858846007178 | Integris | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 49 | 00858846007161 | CMDR.PE.120.60.R | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. | |
| 50 | 00858846007154 | CMDR.TW.120.60.S | This device is intended for use by a qualified/trained physician or technician o This device is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use. This device is a portable line operated diagnostic x-ray unit in combination with a digital x-ray receptor panel and PACS software. It can be used by hospitals, off-site radiography including mobile clinics, military field clinics and nursing homes. | MinXray | MINXRAY, INC. |