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Sign in to claim this brandNovarad Corporation
United States·US-MF-000028327
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3152 N University Avenue, Provo, United States
- Website
- www.novarad.net
- —
- —
- [email protected]
- Phone
- +1 801 642 1001
- PRRC Contact
- Doug Merrill
- EUDAMED SRN
- US-MF-000028327
- FDA FEI Number
- 1000117423
- DUNS Number
- 071991843
Catalogue (53)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NovaPACS | NovaPACS 8.6.8 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 9.1.4 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.7.6 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.7.7 | FDA UDI | Class II | Active |
| OpenSight | OpenSight 1.8706 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.8.4 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.10.5 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.11 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.17 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.7.4 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.1 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.9.1 | FDA UDI | Class II | Active |
| VisAR | VisAR 2.88 | FDA UDI | Class II | Active |
| VisAR | VisAR 2.73 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.8 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.10.3 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.6 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.9 | FDA UDI | Class II | Active |
| OpenSight | OpenSight 1.8076 | FDA UDI | Class II | Active |
| NovaMG™ | NovaMG 1.8.2 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.8.3 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.14 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.12 | FDA UDI | Class II | Active |
| VisAR | VisAR 2.1.5 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.10 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.12 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.5 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.14 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.11 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 9.1.3 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.16 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.10.7 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.3 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.7 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.15 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.4 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.8.5 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.7.8 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.6.7 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.6 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.9.2 | FDA UDI | Class II | Active |
| NovaPACS™ | NovaPACS 8.5.9 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.19 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.5.18 | FDA UDI | Class II | Active |
| NovaPACS | NovaPACS 8.9.3 | FDA UDI | Class II | Active |
| NovaMG | NovaMG 1.8.4 | FDA UDI | Class II | Active |
| NovaMG | NovaMG 1.8.6 | FDA UDI | Class II | Active |
| Novapacs | K063153 | FDA 510(k) | Class II | Active |
| VisAR | K220146 | FDA 510(k) | Class II | Active |
| Novapacs, Novaview, Novacardio, Novaqc And Novaer | K061920 | FDA 510(k) | Class II | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 10, 2019 | Z-2956-2020 | — | terminated | The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on any of the corresponding images that are open. |
| Aug 12, 2016 | Z-2659-2016 | — | terminated | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a "pop-up screen" that was prematurely released. |
| Nov 16, 2015 | Z-1613-2016 | — | terminated | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. |
| May 9, 2013 | Z-2151-2016 | — | terminated | Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. |