No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840682144209 | 5777746 | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | NA | ||
2 | 00840682119658 | 5421698 | IZL | System, x-ray, mobile | 2 | NA | ||
3 | 00195278003348 | Navigate | AMX Navigate Designated Medical Device Assembly | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | AMX | |
4 | 00840682121071 | 4343 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
5 | 00840682120982 | 600FP | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
6 | 00840682120807 | 3543 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
7 | 00840682120784 | 2530 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | Flashpad HD | ||
8 | 00840682119238 | 500D | JAA | System, x-ray, fluoroscopic, image-intensified | 2 | Precision | ||
9 | 00840682143974 | 5607000-2 | KPS | System, tomography, computed, emission | 2 | O560 to 610 Upgrade | ||
10 | 10840682142875 | 690 VCT Boost Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery PET CT | ||
11 | 00840682116732 | 5340000-7 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
12 | 00840682116701 | 5340000-8 | MQB | Solid state x-ray imager (flat panel/digital imager) | 2 | FlashPad | ||
13 | 00840682125574 | Discovery CT A | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
14 | 00840682146616 | Apex | 5590000-20 | Revolution Apex - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
15 | 00840682146357 | OpenOC16 Console Upgrade | KPS | System, tomography, computed, emission | 2 | Discovery IQ | ||
16 | 00840682143981 | 5607000 | KPS | System, tomography, computed, emission | 2 | O560 to D600 Upgrade | ||
17 | 00840682143646 | CT with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
18 | 00840682142601 | 2 | JAK | System, x-ray, tomography, computed | 2 | SnapShot Freeze | ||
19 | 00840682140713 | CT with Quantix Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
20 | 00840682138796 | 160mm Detector Upgrade | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
21 | 00840682123471 | CT ES | 5590000-15 | Revolution CT ES - Designated Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
22 | 00840682118552 | CT | 5590000-6 | Revolution CT - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
23 | 00840682104364 | 5000 | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium | ||
24 | 00840682102490 | Discovery CT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
25 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Omni | |
26 | 00840682125703 | IQ 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
27 | 00840682136709 | XR656 HD Upgrade | XR656HD UDI Label | KPR,MQB | System, X-Ray, Stationary,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Discovery | |
28 | 00840682103107 | IQ | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | ||
29 | 00840682146166 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
30 | 00840682143523 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
31 | 00840682120975 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
32 | 00840682108218 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
33 | 00840682103053 | PETCT 610 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
34 | 00840682102995 | PETCT 710 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
35 | 00195278098603 | MI | PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manuf PET DMI Gen2 Image System Asm, No Detectors Installed, Common Weld Gantry, Manufacturing Make | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | |
36 | 00840682146319 | with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution CT | ||
37 | 00840682141994 | 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery MI Columbird mE2 Application SW | ||
38 | 00840682142168 | XR646 HD Upgrade | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
39 | 00840682147316 | TS-RT-100 | TS-RT-100 | Replacement Tape Blue for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
40 | 00840682147309 | TS-RTW-100 | TS-RTW-100 | Replacement Tape Wide for TruSignal Wrap and Sensitive Skin sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
41 | 00840682147293 | TS-RWM-24 | TS-RWM-24 | Replacement Foam Wrap Medium for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
42 | 00840682147286 | TS-HB-3 | TS-HB-3 | Replacement Headband for TruSignal Ear sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
43 | 00840682147279 | TS-RWS-24 | TS-RWS-24 | Replacement Foam Wrap Small for TruSignal Sensitive Skin sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
44 | 00840682147262 | TS-RTB-100 | TS-RTB-100 | Replacement Tape Bear for TruSignal AllFit sensor, 100 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
45 | 00840682147255 | TS-RWL-24 | TS-RWL-24 | Replacement Foam Wrap for TruSignal Wrap sensor, 24 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
46 | 00840682147248 | TS-SND-3 | TS-SND-3 | Infant Foam Sandal Wrap for TruSignal Sensitive Skin sensor, 3 pcs | DPZ | Oximeter, ear | 2 | TruSignal SpO2 |
47 | 00840682147231 | PACS 1.0 | Designated Medical Device, Critical Care Suite PACS 1.0 | QFM | Radiological computer-assisted prioritization software for lesions | 2 | Critical Care Suite | |
48 | 00840682146340 | 1.0 | QFM,KPS | Radiological computer-assisted prioritization software for lesions,System, tomog Radiological computer-assisted prioritization software for lesions,System, tomography, computed, emission | 2 | Critical Care Suite | ||
49 | 00840682145749 | XR240amx HD Upgrade Gen2 | MQB,IZL | Solid state x-ray imager (flat panel/digital imager),System, x-ray, mobile | 2 | Optima | ||
50 | 00840682122351 | XR240amx | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima |
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 | EKAV101152780 | 1.011.5278 | FP 0203 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
4 | EKAV085004710 | 0.850.0471 | FP 0202 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
5 | EKAV085004700 | 0.850.0470 | FP 0204 | Handheld x-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
6 | EKAV085001120 | 0.850.0112 | AP 0200 | Handheld X-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
7 | EKAV085000300 | 0.850.0030 | FP 0201 | Handheld X-ray | NOMAD MD™ handheld X-ray system | ARIBEX, INC. |
8 | 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 |
9 | 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 |
10 | E31584682012000 | 8468201200 | Analog Panoramic X-Ray Unit with 24x30 cm cassette, including patient positioning items | PantOs 16 xp | FONA SRL | |
11 | 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 | |
12 | E31584682003000 | 8468200300 | Digital Panoramic X-Ray Unit, including patient positioning items | PantOs DG xp | FONA SRL | |
13 | E31584682001000 | 8468200100 | Analog Panoramic X-Ray Unit with 15x30 cm cassette, including patient positioning items | PantOs 16 xp | FONA SRL | |
14 | 00884838090705 | 712035 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
15 | 00884838090699 | 712034 | Stationary x-ray system | DigitalDiagnost C90 | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
16 | 00884838086753 | 4598-013-7583. | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate small | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
17 | 00884838085695 | 9890-010-83904 | 712228 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
18 | 00884838085688 | 9890-010-83904 | 712227 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
19 | 00884838085671 | 9890-010-83904 | 712226 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
20 | 00884838084636 | 4598-012-4298. | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
21 | 00884838074705 | 9897-010-02681 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
22 | 00884838074538 | 9897-010-01041 | 712090 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | ProGrade | PHILIPS MEDICAL SYSTEMS DMC GMBH |
23 | 00884838074521 | 9890-010-83904 | 712033 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
24 | 00884838074514 | 9890-010-83904 | 712032 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
25 | 00884838074279 | 9890-010-87752 | 706050 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Wireless Portable Detector | PHILIPS MEDICAL SYSTEMS DMC GMBH |
26 | 00884838065321 | 9890-010-83904 | 712031 | Stationary x-ray system | DigitalDiagnost | PHILIPS MEDICAL SYSTEMS DMC GMBH |
27 | 00884838065239 | 9897-010-01041 | 712090 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | ProGrade | PHILIPS MEDICAL SYSTEMS DMC GMBH |
28 | 00884838065222 | 9897-010-00834 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate large | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
29 | 00884838065215 | 9897-010-00843 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | SkyPlate small | PHILIPS MEDICAL SYSTEMS DMC GMBH | |
30 | 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. |
31 | 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. |
32 | 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. | |
33 | 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. | |
34 | 00868162000289 | RC-115 | 900035 | X-Ray Control, Remote | RC-115 | SOURCE-RAY, INC. |
35 | 00868162000272 | SR-1260-G | 910222 | X-Ray Generator / Tube Housing Assembly, 120kVp / 60mA | SR-1260-G | SOURCE-RAY, INC. |
36 | 00868162000265 | SR-1260-C | 910224 | X-Ray Control, 120 kVp / 60mA | SR-1260-C | SOURCE-RAY, INC. |
37 | 00868162000258 | SR-130-C | 910002 | X-Ray Control, 100kVp / 30 mA | SR-130-C | SOURCE-RAY, INC. |
38 | 00868162000241 | SR-130-G | 910056 | X-Ray Generator / Tube Housing Assembly, 100kVp / 30mA | SR-130-G | SOURCE-RAY, INC. |
39 | 00868162000234 | SR-115 | 900033 | X-Ray Control / Generator, 100 kVp/ 15mA | SR-115-CG | SOURCE-RAY, INC. |
40 | 00867538000304 | UC-5000 | 900117 | Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Comput Mobile X-Ray System for General Purpose Radiography Exams Utilizing Film, Computed Radiography, or Direct Digital Flat Panels | UC-5000 | SOURCE-RAY, INC. |
41 | 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. | |
42 | 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. | |
43 | 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. | |
44 | 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. | |
45 | 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. | |
46 | 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. | |
47 | 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. | |
48 | 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. | |
49 | 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. | |
50 | 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. |