| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04540217068951 | 503-79869-47 | OWB | Interventional Fluoroscopic X-Ray System | 2 | Trinias | ||
| 2 | 04540217420377 | 228-45196-55 | KIE | Apparatus, High Pressure Liquid Chromatography | 1 | SPD-M30A CL | ||
| 3 | 04540217420384 | 228-45004-22 | KIE | Apparatus, High Pressure Liquid Chromatography | 1 | SPD-20AV CL | ||
| 4 | 04540217068807 | 503-79416-04 | OWB | Interventional Fluoroscopic X-Ray System | 2 | TRINIAS | ||
| 5 | 04540217420391 | 228-45010-22 | KIE | Apparatus, High Pressure Liquid Chromatography | 1 | CTO-20AC CL | ||
| 6 | 04540217420605 | 228-65202-55 | KIE | Apparatus, High Pressure Liquid Chromatography | 1 | CTO-40C CL | ||
| 7 | 04540217420056 | 228-45010-54 | KIE | Apparatus, High Pressure Liquid Chromatography | 1 | CTO-20AC CL | ||
| 8 | 04540217064069 | 562-23372-79 | IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | UD150L-40 | ||
| 9 | 04540217062416 | 563-55050-60 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 10 | 04540217062409 | 563-55050-50 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 11 | 04540217062287 | 582-50301-57 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P366D-150 | ||
| 12 | 04540217062270 | 582-50301-50 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P366D-150 | ||
| 13 | 04540217060832 | 503-79999-11 | IZL | System, X-Ray, Mobile | 2 | MobileDaRt Evolution | ||
| 14 | 04540217060115 | 563-55050-26 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 15 | 04540217059638 | 566-20000-10 | IZL | System, X-Ray, Mobile | 2 | MobileDaRt Evolution | ||
| 16 | 04540217059621 | 503-79999-01 | IZL | System, X-Ray, Mobile | 2 | MobileDaRt Evolution | ||
| 17 | 04540217059546 | 563-55050-32 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 18 | 04540217059539 | 563-55050-31 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 19 | 04540217053506 | 503-79888-41 | IZL | System, X-Ray, Mobile | 2 | MobileDaRt Evolution | ||
| 20 | 04540217053476 | 503-79888-21 | IZL | System, X-Ray, Mobile | 2 | MobileDaRt Evolution | ||
| 21 | 04540217052110 | 562-23372-74 | IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | UD150L-40 | ||
| 22 | 04540217052080 | 502-23372-58 | IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | UD150L-40 | ||
| 23 | 04540217052011 | 563-55050-23 | IZX | Collimator, Manual, Radiographic | 2 | R-20J | ||
| 24 | 04540217032037 | 532-16886-01 | JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | IA-12LT/HS | ||
| 25 | 04540217026081 | 532-16726-62 | JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | IA-16LM(6)/HS12 | ||
| 26 | 04540217020171 | 532-16726-12 | JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 | IA-16LM(6)/HS12 | ||
| 27 | 04540217017522 | 502-23372-53 | IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | UD150L-40 | ||
| 28 | 04540217013579 | 503-51200-43 | IXR | Table, Radiographic, Tilting | 2 | ZS-100IR | ||
| 29 | 04540217013562 | 503-51200-42 | IXR | Table, Radiographic, Tilting | 2 | ZS-100IR | ||
| 30 | 04540217066810 | 566-16610-87 | IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | BR-120T | ||
| 31 | 04540217064779 | 566-16610-86 | IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | BR-120T | ||
| 32 | 04540217064724 | 566-16130-63 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 33 | 04540217064717 | 566-16130-62 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 34 | 04540217064700 | 566-16130-53 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 35 | 04540217064694 | 566-16130-52 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 36 | 04540217064502 | 566-16130-61 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 37 | 04540217064496 | 566-16130-60 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 38 | 04540217064489 | 566-16130-51 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 39 | 04540217064472 | 566-16130-50 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite | ||
| 40 | 04540217062683 | 566-16600-86 | IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | BR-120T | ||
| 41 | 04540217062478 | 566-16600-50 | IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | BR-120T | ||
| 42 | 04540217062294 | 582-24556-50 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P18DE-85 | ||
| 43 | 04540217062164 | 582-24491-57 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P364DK-125 | ||
| 44 | 04540217062157 | 582-24491-50 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P364DK-125 | ||
| 45 | 04540217062126 | 582-24488-57 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P364DK-85 | ||
| 46 | 04540217062119 | 582-24488-50 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P364DK-85 | ||
| 47 | 04540217062072 | 582-24558-57 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P38DE-85 | ||
| 48 | 04540217062065 | 582-24558-50 | ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 0.6/1.2P38DE-85 | ||
| 49 | 04540217060962 | 566-16600-85 | IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | BR-120T | ||
| 50 | 04540217057450 | 566-16130-33 | KPR | System, X-Ray, Stationary | 2 | FDR Visionary Suite |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08904269409531 | 303-000783-4 | Skanrad 400 is an advanced high frequency type X-ray system designed for superio Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation | SKANRAD 400 | SKANRAY TECHNOLOGIES LIMITED | |
| 2 | 08809413810488 | ExamVue DR | The ExamVue DR software is designed for use by radiologists and radiology techni The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. | Box for ExamVue DR(outside 265mmx185mmx150mm) | JPI HEALTHCARE. CO., LTD. | |
| 3 | 08809413810143 | ExamVue DR | The ExamVue DR software is designed for use by radiologists and radiology techni The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. | ExamVue | JPI HEALTHCARE. CO., LTD. | |
| 4 | 08809246620032 | TITAN 11 | TITAN 11 | TITAN 11 is a diagnostic DR System that contains high output capacity and high-r TITAN 11 is a diagnostic DR System that contains high output capacity and high-resolution image processing system. During a surgery, the presence of lesions, size, and location can be recorded easily as Radiography images. The important images can be stored within the device so taking Radiography images is convenient. | SYSTEM, X-RAY, STATIONARY | GEMSS MEDICAL SYSTEMS CO.,LTD. |
| 5 | 08806088670560 | GC70 | The GC70 Digital X-ray Imaging System is intended for use in generating radiogra The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 6 | 08806088566313 | GU60A | The GU60A Digital X-ray Imaging Systems are intended for use in generating radio The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 7 | 08806088565231 | GC85A | The GC85A Digital X-ray Imaging System is intended for use in generating radiogr The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 8 | 08806088520971 | GU60A-65 | The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating ra The GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 9 | 08806088351889 | GF50A | The GF50A Digital X-ray Imaging System is intended for use in generating radiogr The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 10 | 08806088351872 | GF50 | The GF50 Digital X-ray Imaging System is intended for use in generating radiogra The GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 11 | 08806086403467 | GC80 | The GC80 Series Digital X-ray imaging System is intended for use in generating r The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. | NA | SAMSUNG ELECTRONICS CO., LTD. | |
| 12 | 08800018404003 | FLAATZ 500 | The FLAATZ 500 detector is a direct conversion device in the form of a square pl The FLAATZ 500 detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor. | FLAATZ | DRTECH CORPORATION | |
| 13 | 08800011140885 | DIAMOND-5A | 220-230V~/150kV | DRGEM | DRGEM CORPORATION | |
| 14 | 08800011140878 | GXR-82SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 15 | 08800011140861 | GXR-68SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 16 | 08800011140854 | GXR-52SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 17 | 08800011140847 | GXR-40SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 18 | 08800011140830 | GXR-40SD | 380V3~ / 125kV | DRGEM | DRGEM CORPORATION | |
| 19 | 08800011140823 | GXR-32SD | 380V3~ / 150kV | DRGEM | DRGEM CORPORATION | |
| 20 | 08800011140816 | GXR-32SD | 380V3~ / 125kV | DRGEM | DRGEM CORPORATION | |
| 21 | 08800011140809 | SGXR-U40SD | *Line power rating: 100-240V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 22 | 08800011140793 | SGXR-U40SD | *Line power rating: 100-240V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 23 | 08800011140786 | SGXR-U32SD | *Line power rating: 100-240V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 24 | 08800011140779 | SGXR-U32SD | *Line power rating: 100-240V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 25 | 08800011140762 | SGXR-C52SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 26 | 08800011140755 | SGXR-C52SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 27 | 08800011140748 | SGXR-C52SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 28 | 08800011140731 | SGXR-C52SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 29 | 08800011140724 | SGXR-C40SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 30 | 08800011140717 | SGXR-C40SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 31 | 08800011140700 | SGXR-C40SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 32 | 08800011140694 | SGXR-C40SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 33 | 08800011140687 | SGXR-C32SD | *Line power rating: 220-230V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 34 | 08800011140670 | SGXR-C32SD | *Line power rating: 220-230V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 35 | 08800011140663 | SGXR-C32SD | *Line power rating: 110-120V~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 36 | 08800011140656 | SGXR-C32SD | *Line power rating: 110-120V~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 37 | 08800011140649 | SGXR-82SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 38 | 08800011140632 | SGXR-82SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 39 | 08800011140625 | SGXR-82SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 40 | 08800011140618 | SGXR-68SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 41 | 08800011140601 | SGXR-68SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 42 | 08800011140595 | SGXR-68SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 43 | 08800011140588 | SGXR-52SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 44 | 08800011140571 | SGXR-52SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 45 | 08800011140564 | SGXR-52SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 46 | 08800011140557 | SGXR-40SD | *Line power rating: 480V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 47 | 08800011140540 | SGXR-40SD | *Line power rating: 400V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION | |
| 48 | 08800011140533 | SGXR-40SD | *Line power rating: 480V3~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 49 | 08800011140526 | SGXR-40SD | *Line power rating: 400V3~*Max Tube voltage: 125kV | DRGEM | DRGEM CORPORATION | |
| 50 | 08800011140519 | SGXR-40SD | *Line power rating: 380V3~*Max Tube voltage: 150kV | DRGEM | DRGEM CORPORATION |