510(k) Report

FDA applicant

Novarad Corporation

American Fork, UT7 decisions2006–20224 recalls

FDA records 7 decisions for Novarad Corporation (American Fork, UT) from 2006 to 2022: 7 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and OLO (Orthopedic Stereotaxic Instrument). Since 2016 its 510(k)s took a median of 188 days from receipt to decision, against 98 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 4 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Novarad Corp.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Novarad Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014: 12016: 12017: 12018: 12022: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2013: 12015: 12016: 12019: 1
2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Novarad Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Novarad Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological6decisions
  • OLOOrthopedic Stereotaxic Instrument1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 188 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 98 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 13 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K172418OpenSightNovarad Corporation · 20183cite it
  • K171754NovaPACSNovarad Corporation · 20172cite it
  • K160371NovaPACSNovarad Corporation · 20161cites it
  • K132853NovapacsNovarad Corp. · 20141cites it
  • K063153NovapacsNovarad Corp. · 20061cites it
  • K061920Novapacs, Novaview, Novacardio, Novaqc and NovaerNovarad Corp. · 20061cites it

What has FDA decided for it lately?

  • K220146VisARNovarad Corporation · 2022
  • K172418OpenSightNovarad Corporation · 2018
  • K171754NovaPACSNovarad Corporation · 20171 recall
  • K160371NovaPACSNovarad Corporation · 2016
  • K132853NovapacsNovarad Corp. · 20142 recalls
  • K063153NovapacsNovarad Corp. · 20061 recall
  • K061920Novapacs, Novaview, Novacardio, Novaqc and NovaerNovarad Corp. · 2006

All 4 as Novarad Corporation →All 3 as Novarad Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K171754NovaPACS Diagnostic Viewer. NovaPACS is a picture archiving and communication system…Sep 10, 2019Class II
  • K132853NovaPACS versions 8.4.7, 8.5.3, and 8.5.6. Distributed by Novarad Corporation. Picture…Aug 12, 2016Class II
  • K132853NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad CorporationNov 16, 2015Class II
  • K063153NovaPACS  versions 7.4, 7.5, 7.6, and 8.0, Diagnostic Viewer. Distributed by Novarad…May 9, 2013Class II