| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00884838081536 | 45353038409 | Sentinelle MR 1.5T Breast Imaging Table | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 2 | 00884838073159 | 98960320913 | Grid Plate, Enhanced Access, lat. | GDF | GUIDE, NEEDLE, SURGICAL | 1 | Invivo | |
| 3 | 00884838072831 | 98960320335 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 4 | 00884838065673 | 45353025228 | dS Wrist 8CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 5 | 00884838067417 | 45353036082 | SENSE XL Torso Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 6 | 00884838066854 | 45353028072 | dS Breast 16CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 7 | 00884838067240 | 45353031542 | HD 8CH Wrist Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 8 | 00884838067202 | 45353030472 | 1.5T HD T/R Knee Coil (flat base) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 9 | 00884838067189 | 45353031519 | HD 8CH Wrist Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 10 | 00884838067134 | 107629 | HD 8Ch NV Array | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 11 | 00884838067110 | 106614 | HD T/R Quad Extremity Coil | LNH | System, nuclear magnetic resonance imaging | 2 | Invivo | |
| 12 | 00884838067103 | 109183 | HD 8CH Foot Ankle Coil (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 13 | 00884838067097 | 585TO-64 | Phased Array ABFLEX Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 14 | 00884838067042 | 106453 | HD 4Ch Breast Array (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 15 | 00884838066908 | 45353032243 | dS Flex-S | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 16 | 00884838105348 | 4598-018-57611 | dS 1.5T Medial Plug | MOS | Coil, Magnetic Resonance, Specialty | 2 | Sentinelle | |
| 17 | 00884838072978 | 98960320349 | Needle Sleeve | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 18 | 00884838098497 | 459801730021 | dS Knee 16 Ch 1.5T | MOS | Coil, Magnetic Resonance, Specialty | 2 | Invivo | |
| 19 | 00884838065390 | 45353031035 | SENSE MSK M 8CH 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 20 | 00884838086166 | 45980129063 | dS Knee 8Ch 3.0T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 21 | 00884838066953 | 45353033812 | SENSE Torso 8 | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 22 | 00884838066205 | 103345 | Breast Biopsy Array Coil | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 23 | 00884838081529 | 101759 | 1.5T KFA with coil ID | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 24 | 00884838081512 | 472GE-42 | 1.0T Quadrature Lower Extremity Coil | LNH | System, nuclear magnetic resonance imaging | 2 | Invivo | |
| 25 | 00884838073227 | 98960320446 | Bone Biopsy Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 26 | 00884838073210 | 98960320370 | Handle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 27 | 00884838073203 | 98960320369 | Working Tube Set | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 28 | 00884838073197 | 98960320368 | Bone Biopsy Drill Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 29 | 00884838073180 | 98960320365 | Bone Biopsy Set, manual | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 30 | 00884838073173 | 98960320914 | Lateral Grid dS Breast 16CH I/T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 31 | 00884838073166 | 98960320915 | Medial Grid dS Breast 16CH I/T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 32 | 00884838073142 | 98960320912 | Grid Plate, Enhanced Access, med. | GDF | GUIDE, NEEDLE, SURGICAL | 1 | Invivo | |
| 33 | 00884838073135 | 98960320910 | Pillar Immobilization Plate | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 34 | 00884838072848 | 98960320336 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 35 | 00884838072824 | 98960320334 | Coax Needle | KNW | INSTRUMENT, BIOPSY | 2 | Invivo | |
| 36 | 00884838065666 | 100313 | Breast Array Coil (Receive Only) | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 37 | 00884838065659 | 45353005761 | SENSE Head Coil 1.5T/8CH | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 38 | 00884838085510 | 784016 | DynaLync Prostate | OUG | Medical device data system | 1 | Invivo | |
| 39 | 00884838081673 | 45353033613 | dS HiRes Hand/Wrist 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 40 | 00884838081666 | 45980077811 | dS Small Extremity 16ch 3.0T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 41 | 00884838081659 | 45980087863 | dS Small Extremity 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 42 | 00884838081635 | 45353033611 | dS Shoulder 16Ch 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 43 | 00884838081628 | 10606922 | 2 Channel Endo Coil Array for Siemens 3T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 44 | 00884838081611 | 10606920 | Prostate 2 MR Coil 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 45 | 00884838081581 | 45353038361 | Breast MRI 8ch Tabletop for Siemens 3T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 46 | 00884838081604 | 45353038386 | Breast MRI 16ch Tabletop for Siemens 3T | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Invivo | |
| 47 | 00884838081598 | 45353038382 | Breast MRI 16ch Tabletop for Siemens 1.5T | IYN | System, imaging, pulsed doppler, ultrasonic | 2 | Invivo | |
| 48 | 00884838081574 | 45353038349 | Breast MRI 8ch Tabletop for Siemens 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 49 | 00884838081567 | 45353038366 | Breast MRI 4ch Tabletop for Siemens 1.5T | MOS | Coil, magnetic resonance, specialty | 2 | Invivo | |
| 50 | 00884838081543 | 784012 | UroNAV Fusion Biopsy System | JAK | System, x-ray, tomography, computed | 2 | Invivo |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00810040260001 | v1.0 | XR-29 Solution v1.0 | Z-DOSE29 | AGILITI HEALTH, INC. | |
| 2 | 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 | |
| 3 | 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 | |
| 4 | 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 | |
| 5 | 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 | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 00195278592309 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | G E MEDICAL SYSTEMS ISRAEL LTD. | |
| 9 | 00195278469700 | Apex Select | B7919QT-B7919QS | Revolution Apex Select - Designated System Medical Device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. |
| 10 | 00195278454218 | Legend | OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY | Omni | GE MEDICAL SYSTEMS, INC. | |
| 11 | 00195278403087 | Eagle | Revolution Eagle designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 12 | 00195278385215 | Advance | Revolution Advance designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 13 | 00195278363947 | 1.0 | MaxFOV 2 Application Container for Smart Subscription | MaxFOV 2 | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 14 | 00195278362247 | Frontier ES | Revolution Frontier ES for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 15 | 00195278362230 | Frontier MDR | Revolution Frontier for EOL CT Designated medical device | Revolution | HANGWEI GE MEDICAL SYSTEMS CO., LTD. | |
| 16 | 00195278303219 | 1.1 | MAR Application Container for Smart Subscription | MAR | GE HEALTHCARE JAPAN CORPORATION | |
| 17 | 00195278303202 | 1.1 | DLIR Application Container for Smart Subscription | DLIR | GE HEALTHCARE JAPAN CORPORATION | |
| 18 | 00195278303196 | 1.1 | ASiR-V Application Container for Smart Subscription | ASiR-V | GE HEALTHCARE JAPAN CORPORATION | |
| 19 | 00195278118295 | H3911AB | STARGATE NM GANTRY FINAL | StarGuide | G E MEDICAL SYSTEMS ISRAEL LTD. | |
| 20 | 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. | |
| 21 | 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 |
| 22 | 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 |
| 23 | 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 |
| 24 | 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 |
| 25 | 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 |
| 26 | 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 |
| 27 | 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 |
| 28 | 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 |
| 29 | 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 |
| 30 | 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 |
| 31 | 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 |
| 32 | 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 |
| 33 | 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 |
| 34 | 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 |
| 35 | 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 |
| 36 | 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 |
| 37 | 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 |
| 38 | 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 |
| 39 | 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 |
| 40 | 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 |
| 41 | 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 |
| 42 | 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 |
| 43 | 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 |
| 44 | 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 |
| 45 | 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 |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 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 |
| 50 | B887SNMR03503022200 | SNMR-035-030-2220 | SNMR-035-030-2220 | 0.35mm x 3.0cm VISICOIL MR Platinum loaded in an 22 gauge 20cm pre-waxed needle. | VISICOIL MR | RADIOMED CORP |