No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15420045515031 | 2050-0104 | 2050-0104 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
2 | 15420045514089 | R15 | R15 | GDF | GUIDE, NEEDLE, SURGICAL | 1 | PERL | |
3 | 15420045506909 | Discovery C | KGI | Densitometer, bone | 2 | Discovey C | ||
4 | 15420045504110 | ATEC Sapphire 200 | KNW | INSTRUMENT, BIOPSY | 2 | ATEC Sapphire 200 | ||
5 | 15420045510333 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
6 | 15420045514294 | V5 | NSV5US-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
7 | 25420045510330 | 50-250XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MYOSURE XL HYSTEROSCOPY SET | ||
8 | 25420045514307 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
9 | 25420045505107 | 40-902 | 40-902 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
10 | 15420045514836 | PATHVISION 23x29 | PATHVISION23X29 | MWP | Cabinet, x-ray system | 2 | FAXITRON PATH | |
11 | 15420045514300 | V5 | NSV5KITUS-001 | MNB | Device, thermal ablation, endometrial | 3 | NovaSure | |
12 | 15420045512924 | INTERNAL CONTROL-B, 960T, IVD | PRD-06234 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
13 | 15420045512917 | EXTRACTION REAGENTS-B, 960T, IVD | PRD-06232 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | Panther Fusion | |
14 | 15420045510906 | GBS CTRLS KIT, PANTHER FUSION, IVD | PRD-04485 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
15 | 15420045510890 | GBS KIT, 96T, IVD | PRD-04484 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
16 | 15420045510470 | INTERNAL CONTROL-X, 960T, IVD | PRD-04476 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
17 | 15420045510463 | EXTRACTION REAGENT-X, 960T, IVD | PRD-04477 | NJR | Nucleic acid amplification assay system, group b streptococcus, direct specimen test | 1 | Panther Fusion | |
18 | 15420045509641 | System Software | InSight FD | OXO | Image-intensified fluoroscopic x-ray system, mobile | 2 | Flouroscan InSight | |
19 | 15420045509375 | CLASS I CONTROL - C. ALBICANS | PRD-04521 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | aptima | |
20 | 15420045507937 | 20-401ML | 20-401ML | NWW | Hysteroscope accessories | Myosure Manual Tissue Removal Device | ||
21 | 15420045505230 | B90003 | B90003 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4.0-5.0 CM CT LUMEN MARKER SET | |
22 | 15420045505193 | B11245 | B11245 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | 4-5 CM CONTURAFLEX MLB CATHETER w/TRI INTRODUCER | |
23 | 15420045505094 | 50-501XL | 50-501XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
24 | 15420045505087 | 50-401XL | 50-401XL | HIH | HYSTEROSCOPE (AND ACCESSORIES) | 2 | MyoSure Tissue Removal Device | |
25 | 15420045505070 | 30-401LITE | 30-401LITE | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
26 | 15420045505001 | 919007-01 | 919007-01 | JAQ | System, applicator, radionuclide, remote-controlled | Mammosite Variable 4-5 cm Applicator Tray | ||
27 | 15420045504998 | EVIVA_1213-20 | EVIVA_1213-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_1213-20 | ||
28 | 15420045504950 | EVIVA_0910-20 | EVIVA_0910-20 | KNW | INSTRUMENT, BIOPSY | EVIVA_0910-20 | ||
29 | 15420045504813 | 10-401 | 10-401 | HIH | HYSTEROSCOPE (AND ACCESSORIES) | MyoSure Tissue Removal Device | ||
30 | 15420045501140 | 2000 | NS2000US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
31 | 15420045501133 | 2007 | NS2007US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
32 | 15420045501126 | 2013 | NS2013KITUS | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure SureSound | ||
33 | 15420045501119 | 2013 | NS2013US | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | NovaSure | ||
34 | 15420045501065 | Cervista HTA System Computer | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
35 | 15420045500969 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
36 | 15420045500952 | Cervista HTA System | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | Cervista HTA System | ||
37 | 15420045500860 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
38 | 15420045500853 | NovaSure Controller | MNB | DEVICE, THERMAL ABLATION, ENDOMETRIAL | 3 | NovaSure | ||
39 | 15420045512474 | GENIUS AI DETECTION SOFTWARE | OTE | Digital breast tomosynthesis | 3 | GENIUS AI DETECTION | ||
40 | 25420045510064 | FILTER, THINPREP UROCYTE 100 PACK | 70472-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
41 | 25420045510057 | THINPREP SLIDES UROCYTE, 100 pk | 70471-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
42 | 25420045509990 | THINPREP MICROSCOPE, ARCLESS, 72pk | 70126-002 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
43 | 25420045509679 | NON-GYN Slides | 70372-001 | KEW | SLIDES, MICROSCOPE | ThinPrep | ||
44 | 25420045509662 | NON-GYN Filters, 100 pack | 70205-001 | KET | FILTERS, CELL COLLECTION, TISSUE PROCESSING | ThinPrep | ||
45 | 25420045508467 | UroCyte Vial | 70473-001 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
46 | 25420045505039 | 819001 | 819001 | JAQ | System, applicator, radionuclide, remote-controlled | 2 | Neucletron HDR Afterloader Connectors wObturators | |
47 | 15420045514775 | PRESERVCYT VIAL | PRD-07129 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
48 | 15420045514621 | UroCyte Vial | ASY-15509 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
49 | 15420045514614 | CytoLyt Cup | PRD-07065 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep | |
50 | 15420045514607 | CytoLyt Tube | PRD-07064 | LEA | PRESERVATIVE, CYTOLOGICAL | 1 | ThinPrep |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B295VNA70 | 7 | PACSCore VNA archive with remote, remote backup, and optional local repositories PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive | Vendor Neutral Archive with ConnectWeb | RADIUS | |
2 | B295VBB60 | 6 | Basic radiologist workstation | ViewBox Basic | RADIUS | |
3 | B295VBA10 | 1 | Advanced radiologist workstation | ViewBox Advanced | RADIUS | |
4 | B295PACSCORE60 | 6 | PACSCore back-end archive | PACSCore | RADIUS | |
5 | B295FULLPACS30 | 3 | ConnectWeb viewer front-end with PACSCore back-end archive | ConnectWeb with PACSCore | RADIUS | |
6 | B295DICOMFWD30 | 3 | Basic DICOM gateway | DicomForward | RADIUS | |
7 | B220843002A8430031 | Eureka AI Interoperability Platform | An application software program designed to function as a portal to allow softwa An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility. | Eureka | TERARECON INC. | |
8 | B2208430011 | Eureka AI Results Explorer | Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is Eureka AI Results Explorer (aka Northstar AI Results Explorer and Northstar) is a zero-footprint, web-based software device indicated for use in clinical settings where medical images and image-derived metadata can be accessed or visualized to aid healthcare professionals in diagnosis and patient management decision making. Eureka AI Results Explorer’s web interfaces can obtain and consume both DICOM and non-DICOM image-derived metadata generated by Artificial Intelligence (AI) or computer vision algorithms. | Eureka | TERARECON INC. | |
9 | AMBRMOBILEAPP0 | AMBRMOBILEAPP0 | Mobile Application version of Ambra Health. Not intended for diagnostic purposes. | Ambra Health Mobile Application | AMBRA HEALTH | |
10 | 60889978671366 | Vue RIS | 8671364 | RIS SOFTWARE < 25K EXAMS / YEAR | Vue RIS | CARESTREAM HEALTH, INC. |
11 | 60889976574645 | DRX - Ascend System | 6574644 | QG-TV-CM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
12 | 60889976574638 | DRX - Ascend System | 6574636 | QG-TV10-C TECHVISION RS-590 WITH Q-VISIO | DRX - Ascend System | CARESTREAM HEALTH, INC. |
13 | 60889976573341 | QG-TV-IP-FM | 6573349 | QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT | QG-TV-IP-FM | CARESTREAM HEALTH, INC. |
14 | 60889976573334 | QG-TV-IP-F | 6573331 | QG-TV10-IPF TECHVISION QS-550 WITH DRX | QG-TV-IP-F | CARESTREAM HEALTH, INC. |
15 | 60889976573327 | QG-TV-IP-CM | 6573323 | QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT | QG-TV-IP-CM | CARESTREAM HEALTH, INC. |
16 | 60889976573310 | QG-TV-IP-C | 6573315 | QG-TV10-IPC TECHVISION RS-590 WITH DRX | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
17 | 60889976571866 | DRX - Ascend System | 6571863 | TECHVISIN SYSTM,RS-590 WIT | DRX - Ascend System | CARESTREAM HEALTH, INC. |
18 | 60889974005226 | DRX - Ascend System | 1025907 | TECHVISION FOR CEILING SYSTEM | DRX - Ascend System | CARESTREAM HEALTH, INC. |
19 | 60889971065391 | QG-TV-IP-C | 1065390 | Techvision for Ceiling Systm | QG-TV-IP-C | CARESTREAM HEALTH, INC. |
20 | 15420045515369 | Cenova Server | Cenova | HOLOGIC, INC. | ||
21 | 15420045515345 | Cenova Server | Cenova | HOLOGIC, INC. | ||
22 | 15420045507449 | DICOM 6000 | DICOM 6000 | HOLOGIC, INC. | ||
23 | 15420045507395 | Cenova Server | Cenova | HOLOGIC, INC. | ||
24 | 15420045507388 | SVDX Manager | SecurView DX Manager | HOLOGIC, INC. | ||
25 | 15420045507371 | SVRT Manager | SecurViewRT Manager | HOLOGIC, INC. | ||
26 | 15420045507364 | SVRT | SecurViewRT Mammorgraphy Workstation | HOLOGIC, INC. | ||
27 | 10841736111731 | SDS | SVIS-SDS | SDS INTEGRATION W/22" TP | SkyVision | SKYTRON LLC |
28 | 10841736111724 | LINX 300 | SVIS-LINX | SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Pane SkyVision LINX 300 Digital Integration system includes: Medical Grade Touch Panel, Optical Router, IP addressable Control Switch and On-Board Uninterruptable Power Supply. | SkyVision | SKYTRON LLC |
29 | 09421904268074 | 1.3 | VolparaServer 1.3 | VolparaServer | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
30 | 09353278000656 | P006598 | Kosmos UP | ECHONOUS, INC. | ||
31 | 08809278790345 | INFINITT RT Mobile | INFINITT RT Mobile | INFINITT HEALTHCARE CO.,LTD. | ||
32 | 07540293000033 | Archer 20 | Router for Tipso Airpad (TIPSO Router) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
33 | 07540293000026 | APADCHG-APL2 | Charging Dock (TIPSO AirPad® Charger) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
34 | 07540293000019 | UDNG-UD4 | TIPSO USB Dongle | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
35 | 07540293000002 | APAD-APL2 | Tipso Airpad (A wireless controller) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
36 | 05415334039773 | MDRC-2222 | K9307942B | MDRC-2222 CK CT MK2 | Barco | BARCO NV |
37 | 05415334039766 | MDRC-2222 | K9307935B | MDRC-2222 CK C MK2 | Barco | BARCO NV |
38 | 05415334039759 | MDRC-2222 | K9307947B | MDRC-2222 WH MK2 | Barco | BARCO NV |
39 | 05415334039742 | MDRC-2222 | K9307945B | MDRC-2222 WP MK2 | Barco | BARCO NV |
40 | 05415334039728 | MDRC-2222 | K9307943B | MDRC-2222 TS MK2 | Barco | BARCO NV |
41 | 05415334038547 | MDRC-2222 | K9307944B | MDRC-2222 BL MK2 | Barco | BARCO NV |
42 | 05415334036260 | MDRC-2324 | 300006378031 | MDRC-2324 SPIB PHC | Barco | FIMI SRL |
43 | 05415334028869 | MDRC-1219 | 991932952081 | MDRC-1219 | Barco | BARCO NV |
44 | 05415334026926 | MDRC-1219 | K9301820ABR | MDRC-1219 | Barco | BARCO NV |
45 | 05415334026919 | MDRC-1219 | K9301821ABR | MDRC-1219 TS | Barco | BARCO NV |
46 | 05415334026025 | MDRC-2324 | K96101371 | MDRC-2324 SNIB CHH | Barco | FIMI SRL |
47 | 05415334025158 | MDRC-2321 | K9350315 | MDRC-2321 SNIB HLX | Barco | BARCO NV |
48 | 05415334025134 | MDRC-2321 | K9610112 | MDRC-2321 SNIB | Barco | BARCO NV |
49 | 05415334024106 | Acquiris 19 | K9350281 | MDRC-1219 HB | Barco | BARCO NV |
50 | 05415334023253 | MDRC-2222 | K9307943BR | MDRC-2222 TS | Barco | BARCO NV |