Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Novarad with 7 510(k) clearances and 4 device recalls. The most recent is a 510(k) clearance dated May 27, 2022: VisAR.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 27, 2022 | VisARK220146 · OLO | 510(k) clearances |
| Sep 10, 2019 | NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system software that retrieves, distributes, and display imageClass II · The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images | Device recalls |
| Sep 21, 2018 | OpenSightK172418 · LLZ | 510(k) clearances |
| Jul 28, 2017 | NovaPACSK171754 · LLZ | 510(k) clearances |
| Oct 14, 2016 | NovaPACSK160371 · LLZ | 510(k) clearances |
| Aug 12, 2016 | NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture archiving and communication system (PACS) Product UClass II · 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-u | Device recalls |
| Nov 16, 2015 | NovaPACS Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad CorporationClass II · The SUV values that are being calculated in the PET/CT fusion tool are incorrect. | Device recalls |
| Oct 30, 2014 | NOVAPACSK132853 · LLZ | 510(k) clearances |
| May 9, 2013 | NovaPACS versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad Corporation. Picture archiving and communication systeClass II · Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. | Device recalls |
| Dec 7, 2006 | NOVAPACSK063153 · LLZ | 510(k) clearances |
| Aug 21, 2006 | NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAERK061920 · LLZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
