| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03770019599013 | v1.2.0 | inHEART Models Shaper is a medical image processing and visualization software f inHEART Models Shaper is a medical image processing and visualization software for manual 3D segmentation including cardiac images. It provides simple image review software functionality for basic medical image processing and manipulation, such as grayscale window and level, zoom and pan, image reformat, thresholding or user delineated geometric measurements (distance and volume). It is intended to be used by inHEART trained staffs.inHEART Models Shaper is part of the inHEART Models service that provides digital 3D models from medical images (CT and/or MR) intended to be used by qualified medical professionals (including physicians, cardiologists, radiologists and technicians).Clinicians are solely responsible for making all final patient management decisions. | LMD | System, Digital Image Communications, Radiological | 1 | inHEART Models Shaper |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 15420045515369 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 2 | 15420045515345 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 3 | 15420045507449 | DICOM 6000 | DICOM 6000 | HOLOGIC, INC. | ||
| 4 | 15420045507395 | Cenova Server | Cenova | HOLOGIC, INC. | ||
| 5 | 15420045507388 | SVDX Manager | SecurView DX Manager | HOLOGIC, INC. | ||
| 6 | 15420045507371 | SVRT Manager | SecurViewRT Manager | HOLOGIC, INC. | ||
| 7 | 15420045507364 | SVRT | SecurViewRT Mammorgraphy Workstation | HOLOGIC, INC. | ||
| 8 | 10841736111731 | SDS | SVIS-SDS | SDS INTEGRATION W/22" TP | SkyVision | SKYTRON LLC |
| 9 | 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 |
| 10 | 09421904268074 | 1.3 | VolparaServer 1.3 | VolparaServer | VOLPARA HEALTH TECHNOLOGIES LIMITED | |
| 11 | 09353278000656 | P006598 | Kosmos UP | ECHONOUS, INC. | ||
| 12 | 08809278790345 | INFINITT RT Mobile | INFINITT RT Mobile | INFINITT HEALTHCARE CO.,LTD. | ||
| 13 | 07540293000033 | Archer 20 | Router for Tipso Airpad (TIPSO Router) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 14 | 07540293000026 | APADCHG-APL2 | Charging Dock (TIPSO AirPad® Charger) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 15 | 07540293000019 | UDNG-UD4 | TIPSO USB Dongle | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 16 | 07540293000002 | APAD-APL2 | Tipso Airpad (A wireless controller) | NZ Technologies Inc | NZ TECHNOLOGIES INC | |
| 17 | 05415334039773 | MDRC-2222 | K9307942B | MDRC-2222 CK CT MK2 | Barco | BARCO NV |
| 18 | 05415334039766 | MDRC-2222 | K9307935B | MDRC-2222 CK C MK2 | Barco | BARCO NV |
| 19 | 05415334039759 | MDRC-2222 | K9307947B | MDRC-2222 WH MK2 | Barco | BARCO NV |
| 20 | 05415334039742 | MDRC-2222 | K9307945B | MDRC-2222 WP MK2 | Barco | BARCO NV |
| 21 | 05415334039728 | MDRC-2222 | K9307943B | MDRC-2222 TS MK2 | Barco | BARCO NV |
| 22 | 05415334038547 | MDRC-2222 | K9307944B | MDRC-2222 BL MK2 | Barco | BARCO NV |
| 23 | 05415334036260 | MDRC-2324 | 300006378031 | MDRC-2324 SPIB PHC | Barco | FIMI SRL |
| 24 | 05415334028869 | MDRC-1219 | 991932952081 | MDRC-1219 | Barco | BARCO NV |
| 25 | 05415334026926 | MDRC-1219 | K9301820ABR | MDRC-1219 | Barco | BARCO NV |
| 26 | 05415334026919 | MDRC-1219 | K9301821ABR | MDRC-1219 TS | Barco | BARCO NV |
| 27 | 05415334026025 | MDRC-2324 | K96101371 | MDRC-2324 SNIB CHH | Barco | FIMI SRL |
| 28 | 05415334025158 | MDRC-2321 | K9350315 | MDRC-2321 SNIB HLX | Barco | BARCO NV |
| 29 | 05415334025134 | MDRC-2321 | K9610112 | MDRC-2321 SNIB | Barco | BARCO NV |
| 30 | 05415334024106 | Acquiris 19 | K9350281 | MDRC-1219 HB | Barco | BARCO NV |
| 31 | 05415334023253 | MDRC-2222 | K9307943BR | MDRC-2222 TS | Barco | BARCO NV |
| 32 | 05415334023246 | MDRC-2222 | K9307947BR | MDRC-2222 WH | Barco | BARCO NV |
| 33 | 05415334023239 | MDRC-2222 | K9307945BR | MDRC-2222 WP | Barco | BARCO NV |
| 34 | 05415334020948 | MDRC-2222 | K9307944BR | MDRC-2222 BL | Barco | BARCO NV |
| 35 | 05415334004627 | MDRC-2222 | K9307935 | MDRC-2222 CK C | Barco | BARCO NV |
| 36 | 05415334004610 | MDRC-2222 | K9307942 | MDRC-2222 CK CT | Barco | BARCO NV |
| 37 | 05415334003149 | MDRC-2324 | K9350081 | MDRC-2324 HNEW | Barco | FIMI SRL |
| 38 | 05415334003132 | MDRC-2324 | K9350080 | MDRC-2324 HTIB | Barco | FIMI SRL |
| 39 | 05415334003118 | MDRC-2324 | K9350071 | MDRC-2324 HTEW | Barco | FIMI SRL |
| 40 | 05415334003101 | MDRC-2324 | K9350070 | MDRC-2324 HNIB | Barco | FIMI SRL |
| 41 | 05415334003095 | MDRC-2324 | K9350056 | MDRC-2324 STIB | Barco | FIMI SRL |
| 42 | 05415334002975 | Acquiris 19 | K9350031 | MDRC-1219 HB TS | Barco | BARCO NV |
| 43 | 05415334002968 | Acquiris 19 | K9350030 | MDRC-1219 HB | Barco | BARCO NV |
| 44 | 05415334002272 | MDRC-2321 | K9350054 | MDRC-2321 STIB | Barco | FIMI SRL |
| 45 | 05415334002258 | MDRC-2321 | K9350052 | MDRC-2321 HTIB | Barco | FIMI SRL |
| 46 | 05415334002241 | MDRC-2321 | K9350051 | MDRC-2321 HNIB | Barco | FIMI SRL |
| 47 | 05415334002210 | MDRC-1219 | K9307953 | MDRC-1219 | Barco | BARCO NV |
| 48 | 05415334001152 | MDRC-1219 | K9301820A | MDRC-1219 | Barco | BARCO NV |
| 49 | 05415334001145 | MDRC-1219 | K9301821A | MDRC-1219 TS | Barco | BARCO NV |
| 50 | 05415334000537 | MDRC-2224 BL | Clinical review 2MP | BARCO NV |