| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B7671R522 | 5.2.2 | Rapid | Rapid System Update | LLZ,POK,QAS | System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid |
| 2 | B7671R521 | 5.2.2 | Rapid | POK,LLZ,QAS | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,System, Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | |
| 3 | B7671R520 | 5.2.0 | Rapid | LLZ,POK,QAS | System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For System, Image Processing, Radiological,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | |
| 4 | B7671R512 | 5.1.2 | Rapid | POK,QAS,LLZ | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiolog Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software,System, Image Processing, Radiological | 2 | Rapid | |
| 5 | B7671R511 | 5.1.1 | Rapid | POK,QAS,LLZ | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiolog Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer,Radiological Computer-Assisted Triage And Notification Software,System, Image Processing, Radiological | 2 | Rapid | |
| 6 | B7671R5030 | 5.0.3 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | Rapid | ||
| 7 | B761RAPID510 | 5.1 | Rapid 5.1 | LLZ,QAS,POK | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software,Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 | Rapid | |
| 8 | B761RAPID50210 | 5.0.2.1 | Rapid | Rapid | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID |
| 9 | B761RAPID5020 | 5.0.2 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID | ||
| 10 | B761RAPID5010 | 5.0.1 | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID | ||
| 11 | B761RAPID500 | 5.0 | Rapid | Rapid | LLZ,QAS | System, Image Processing, Radiological,Radiological Computer-Assisted Triage And System, Image Processing, Radiological,Radiological Computer-Assisted Triage And Notification Software | 2 | RAPID |
| 12 | B761RAPID48302 | 4.8.3 | RAPID | RAPID is a Platform for brain image analysis. | LLZ | System, Image Processing, Radiological | 2 | RAPID |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 05420060346019 | HEAPR-01-001-01 | HEAPR-01-001-01 | Heartprint medical model, SLS | HeartPrint | MATERIALISE NV |
| 2 | 05420060346002 | HEAPR-01-002-01 | HEAPR-01-002-01 | Heartprint medical model, SLA | HeartPrint | MATERIALISE NV |
| 3 | 05415334037533 | MDNC-2221 | K9301648D | Diagnostic display MDNC-2221 | Nio Color 2MP LED | BARCO NV |
| 4 | 05415334037526 | MDNC-2221 | K9301649D | Diagnostic display MDN-2221 NC | Nio Color 2MP LED | BARCO NV |
| 5 | 05415334031609 | MDNC-2221 | K9301648C | MDNC-2221 MKIII | Nio Color 2MP LED | BARCO NV |
| 6 | 05415334031593 | MDNC-2221 | K9301649C | MDNC-2221 NC MKIII | Nio Color 2MP LED | BARCO NV |
| 7 | 05415334030411 | MDNG-5221 | K9300350C | MDNG-5221 CB MKIII | Nio 5MP LED | BARCO NV |
| 8 | 05415334030329 | MDCG-5221 | K9301540C | MDCG-5221 CB MKIII | Coronis 5MP LED | BARCO NV |
| 9 | 05415334030312 | MDNG-5221 | K9300351C | MDNG-5221 BB MKIII | Nio 5MP LED | BARCO NV |
| 10 | 05415334002005 | MDNC-2221 | K9301654B | MDNC-2221 EM | Nio Color 2MP | BARCO NV |
| 11 | 05415334001589 | MDMG-5121 | K9300508A | Coronis 5MP Mammo | BARCO NV | |
| 12 | 05415334001572 | MDMG-5221 | K9300521B | MDMG-5221 CB | Barco Mammo Tomosynthesis | BARCO NV |
| 13 | 05415334001565 | MDMG-5221 | K9300520B | MDMG-5221 | Barco Mammo Tomosynthesis | BARCO NV |
| 14 | 05415334001558 | MDCG-5121 | K9301500B | Coronis 5MP | BARCO NV | |
| 15 | 05415334001541 | MDNG-5121 | K9300266C | MDNG-5121 CB (MA) | MDNG-5121 CB (MA) | BARCO NV |
| 16 | 05415334001534 | MDMG-5221 | K9300521A | MDMG-5221 CB | Barco Mammo Tomosynthesis | BARCO NV |
| 17 | 05415334001527 | MDMG-5221 | K9300520A | MDMG-5221 BB | Barco Mammo Tomosynthesis | BARCO NV |
| 18 | 05415334001510 | MDCC-4130 | K9301605A | Coronis Fusion 4MP | BARCO NV | |
| 19 | 05415334001503 | MDMG-5121 | K9300507A | Coronis 5MP Mammo | BARCO NV | |
| 20 | 05415334001497 | MDCG-10130 | K9301660A | Coronis Fusion 10MP | BARCO NV | |
| 21 | 05415334001480 | MDNG-6121 | K9301650A | Nio 5MP | BARCO NV | |
| 22 | 05415334001473 | MDNG-5121 | K9300268B | MDNG-5121 BB MA GE BUC MKII | NIO 5MP | BARCO NV |
| 23 | 05415334001466 | MDNG-5121 | K9300321A | MDNG-5121 MKII | NIO 5MP | BARCO NV |
| 24 | 05415334001459 | MDNG-5121 | K9300267C | MDNG-5121 BB MA MKII | NIO 5MP | BARCO NV |
| 25 | 05415334001442 | E-3620 | K9300289D | E-3620 MA LORAD G | Nio 3MP | BARCO NV |
| 26 | 05415334001435 | E-3620 | K9300248B | E-3620 MA | Nio 3MP | BARCO NV |
| 27 | 05415334001121 | MDNC-3421 | K9300343A | MDNC-3421 CN | Nio Color 3MP LED | BARCO NV |
| 28 | 05415334001114 | MDNC-3421 | K9300342A | MDNC-3421LE | Nio Color 3MP LED | BARCO NV |
| 29 | 05415334001107 | MDNC-3421 | K9300341A | MDNC-3421 NC | Nio Color 3MP LED | BARCO NV |
| 30 | 05415334000513 | MDCC-6430 | K9301635B | Coronis Fusion 6MP LED | BARCO NV | |
| 31 | 05415334000322 | MDNC-2221 | K9301653B | MDNC-2221 HE MK II | Nio Color 2MP HB | BARCO NV |
| 32 | 05415334000315 | MDNC-2221 | K9301653A | MDNC-2221 HE | Nio Color 2MP HB | BARCO NV |
| 33 | 05415334000308 | MDNC-2221 | K9301649B | MDNC-2221 W/O FF MKII | Nio Color 2MP HB | BARCO NV |
| 34 | 05415334000292 | MDNC-2221 | K9301649A | MDNC-2221 W/O FF | Nio Color 2MP HB | BARCO NV |
| 35 | 05415334000285 | MDNC-2221 | K9301648B | MDNC-2221 MKII | Nio Color 2MP HB | BARCO NV |
| 36 | 05415334000278 | MDNC-2221 | K9301648A | Nio Color 2MP HB | BARCO NV | |
| 37 | 05415334000261 | MDCC-6430 | K9301635A | Coronis Fusion 6MP LED | BARCO NV | |
| 38 | 05415334000254 | MDCC-6330 | Coronis Fusion 6MP LED | BARCO NV | ||
| 39 | 05415334000162 | MDCG-3221 | Coronis 3MP LED | BARCO NV | ||
| 40 | 05415334000155 | MDMG-5221 | Barco Mammo Tomosynthesis | BARCO NV | ||
| 41 | 05415334000124 | MDMG-5121 | Coronis 5MP Mammo | BARCO NV | ||
| 42 | 05415334000117 | MDNG-5221 | K9300351B | MDNG-5221 BB | Nio 5MP LED | BARCO NV |
| 43 | 05415334000100 | MDNG-5221 | K9300351A | MDNG-5221 BB | Nio 5MP LED | BARCO NV |
| 44 | 05415334000094 | MDNG-5221 | K9300350B | MDNG-5221 CB | Nio 5MP LED | BARCO NV |
| 45 | 05415334000087 | MDNG-5221 | K9300350A | MDNG-5221 CB | Nio 5MP LED | BARCO NV |
| 46 | 05415334000063 | MDNC-3321 | K9300328A | MDNC-3321 HLX | Nio Color 3MP LED | BARCO NV |
| 47 | 05415334000049 | MDNC-3321 | K9300325A | MDNC-3321 LE | Nio Color 3MP LED | BARCO NV |
| 48 | 05415334000032 | MDNC-3321 | K9300324A | MDNC-3321 W/O FF | Nio Color 3MP LED | BARCO NV |
| 49 | 05415334000025 | MDNC-3321 | K9300323A | Nio Color 3MP LED | BARCO NV | |
| 50 | 05415067003027 | 100037184 | 100037184 | Software Installation | EnSite⢠| ST. JUDE MEDICAL, INC. |