| 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 | 00840682123471 | CT ES | 5590000-15 | Revolution CT ES - Designated Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 21 | 00840682118552 | CT | 5590000-6 | Revolution CT - Designated System Medical Device | JAK | System, x-ray, tomography, computed | 2 | Revolution |
| 22 | 00840682104364 | 5000 | KPR,MQB | System, x-ray, stationary,Solid state x-ray imager (flat panel/digital imager) | 2 | Definium | ||
| 23 | 00840682102490 | Discovery CT | JAK | System, x-ray, tomography, computed | 2 | Revolution | ||
| 24 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Omni | |
| 25 | 00840682125703 | IQ 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 26 | 00840682136709 | XR656 HD Upgrade | XR656HD UDI Label | KPR,MQB | System, X-Ray, Stationary,Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | Discovery | |
| 27 | 00840682103107 | IQ | JAK,KPS | System, x-ray, tomography, computed,System, tomography, computed, emission | 2 | Discovery | ||
| 28 | 00840682146166 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 29 | 00840682143523 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 30 | 00840682120975 | MI Digital Ready | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 31 | 00840682108218 | MI | KPS,JAK | System, tomography, computed, emission,System, x-ray, tomography, computed | 2 | Discovery | ||
| 32 | 00840682103053 | PETCT 610 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 33 | 00840682102995 | PETCT 710 | KPS | System, tomography, computed, emission | 2 | Discovery | ||
| 34 | 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 | |
| 35 | 00840682146319 | with Apex edition | JAK | System, x-ray, tomography, computed | 2 | Revolution CT | ||
| 36 | 00840682141994 | 2.0 | KPS | System, tomography, computed, emission | 2 | Discovery MI Columbird mE2 Application SW | ||
| 37 | 00840682123686 | XR240amx HD Upgrade | IZL,MQB | System, x-ray, mobile,Solid state x-ray imager (flat panel/digital imager) | 2 | Optima | ||
| 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 | 00811907031819 | LIA-01-001 | The Lung Image Analysis (LIA) software is designed to aid in the interpretation The Lung Image Analysis (LIA) software is designed to aid in the interpretation of Computed Tomography (CT) scans of the thorax that may contain pulmonary abnormalities. Lung Image Analysis has both a graphical user interface and command-line software which can be run as a Windows application or from a command-line interpreter. The LIA software is to be used by trained professionals who are responsible for the correct and accurate use of medical images. In a typical clinical environment, the results provided by the software are used together with other clinical information by a medical professional.The software may be installed on an off-the-shelf PC computer system and is intended to be used with uncompressed digital images that are saved in DICOM format. | Lung Image Analysis | PULMONX CORPORATION | |
| 2 | 00810040260001 | v1.0 | XR-29 Solution v1.0 | Z-DOSE29 | AGILITI HEALTH, INC. | |
| 3 | 00810030350095 | uMI 550 VM | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. | uMI VM | UIH TECHNOLOGIES LLC | |
| 4 | 00810030350088 | uMI 550 | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing ima The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. This system is intended to be operated by qualified healthcare professionals. | uMI | UIH TECHNOLOGIES LLC | |
| 5 | 00810030350040 | uCT 780 | The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). | uCT | UIH TECHNOLOGIES LLC | |
| 6 | 00810030350033 | uCT 760 | The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray The uCT Computed Tomography X-ray System uCT 760 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular). | uCT | UIH TECHNOLOGIES LLC | |
| 7 | 00810030350026 | uCT 550 | The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular. | uCT | UIH TECHNOLOGIES LLC | |
| 8 | 00810030350019 | uCT 530 | The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray The uCT Computed Tomography X-ray System uCT 530 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body, including head, neck, cardiac (calcium scoring) and vascular. | uCT | UIH TECHNOLOGIES LLC | |
| 9 | 00195278592309 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | G E MEDICAL SYSTEMS ISRAEL LTD. | |
| 10 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
| 11 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | GE MEDICAL SYSTEMS, INC. | |
| 12 | 00195278403087 | Eagle | Revolution Eagle designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 13 | 00195278385215 | Advance | Revolution Advance designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 14 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | MaxFOV 2 | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 15 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 16 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 17 | 00195278303219 | 1.1 | MAR Application Container for Smart Subscription | MAR | GE HEALTHCARE JAPAN CORPORATION | |
| 18 | 00195278303202 | 1.1 | DLIR Application Container for Smart Subscription | DLIR | GE HEALTHCARE JAPAN CORPORATION | |
| 19 | 00195278303196 | 1.1 | ASiR-V Application Container for Smart Subscription | ASiR-V | GE HEALTHCARE JAPAN CORPORATION | |
| 20 | 00195278118295 | H3911AB | STARGATE NM GANTRY FINAL | StarGuide | G E MEDICAL SYSTEMS ISRAEL LTD. | |
| 21 | 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 | Discovery | GE MEDICAL SYSTEMS, INC. | |
| 22 | B887VC110030PL0 | VC-110-030-PL | VC-110-030-PL | 1.10mm x 3.0cm VISICOIL loaded in an 17 gauge brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 23 | B887VC110020PL300 | VC-110-020-PL30 | VC-110-020-PL30 | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 24 | B887VC110020PL0 | VC-110-020-PL | VC-110-020-PL | 1.10mm x 2.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 25 | B887VC110010PL300 | VC-110-010-PL30 | VC-110-010-PL30 | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 26 | B887VC110010PL0 | VC-110-010-PL | VC-110-010-PL | 1.10mm x 1.0cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 27 | B887VC110005PL0 | VC-110-005-PL | VC-110-005-PL | 1.10mm x 0.5cm VISICOIL loaded in an 17 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 28 | B887VC075030PL0 | VC-075-030-PL | VC-075-030-PL | 0.75mm x 3.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 29 | B887VC075020PL300 | VC-075-020-PL30 | VC-075-020-PL30 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 30 | B887VC075020PL120 | VC-075-020-PL12 | VC-075-020-PL12 | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 31 | B887VC075020PL0 | VC-075-020-PL | VC-075-020-PL | 0.75mm x 2.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 32 | B887VC075010PL300 | VC-075-010-PL30 | VC-075-010-PL30 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 33 | B887VC075010PL120 | VC-075-010-PL12 | VC-075-010-PL12 | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 34 | B887VC075010PL0 | VC-075-010-PL | VC-075-010-PL | 0.75mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 35 | B887VC075005PL300 | VC-075-005-PL30 | VC-075-005-PL30 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 36 | B887VC075005PL120 | VC-075-005-PL12 | VC-075-005-PL12 | 0.75mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 37 | B887VC075005PL0 | VC-075-005-PL | VC-075-005-PL | 0.75mm x 0.50cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 38 | B887VC050020PLSL0 | VC-050-020-PLSL | VC-050-020-PLSL | 0.50mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 39 | B887VC050020PL0 | VC-050-020-PL | VC-050-020-PL | 0.5mm x 2.0cm VISICOIL loaded in a 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 40 | B887VC050010PLSL0 | VC-050-010-PLSL | VC-050-010-PLSL | 0.5mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 41 | B887VC050010PL300 | VC-050-010-PL30 | VC-050-010-PL30 | 0.5mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 42 | B887VC050010PL0 | VC-050-010-PL | VC-050-010-PL | 0.50mm x 1.0cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 43 | B887VC050005PLSL0 | VC-050-005-PLSL | VC-050-005-PLSL | 0.50mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 44 | B887VC050005PL300 | VC-050-005-PL30 | VC-050-005-PL30 | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 45 | B887VC050005PL0 | VC-050-005-PL | VC-050-005-PL | 0.50mm x 0.5cm VISICOIL loaded in an 18 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 46 | B887VC035040PL0 | VC-035-040-PL | VC-035-040-PL | 0.35mm x 4.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 47 | B887VC035030PL0 | VC-035-030-PL | VC-035-030-PL | 0.35mm x 3.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 48 | B887VC035020PL0 | VC-035-020-PL | VC-035-020-PL | 0.35mm x 2.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 49 | B887VC035010PL0 | VC-035-010-PL | VC-035-010-PL | 0.35mm x 1.0cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |
| 50 | B887VC035005PL0 | VC-035-005-PL | VC-035-005-PL | 0.35mm x 0.5cm VISICOIL loaded in an 19 gauge pre-waxed brachytherapy needle. | VISICOIL | RADIOMED CORP |