510(k) Report

FDA applicant

Nview Medical

Salt Lake City, UT3 decisions2019–20220 recalls

FDA records 3 decisions for Nview Medical (Salt Lake City, UT) from 2019 to 2022: 3 510(k) clearances. All are in product code OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 203 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Nview Medical, Inc.”.

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 Nview Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12021: 12022: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Nview Medical by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • OWBInterventional Fluoroscopic X-Ray System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 203 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 2 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190064nView system 1Nview Medical, Inc. · 20191cites it
  • K211064nView s1 with nav optionNview Medical · 20211cites it

What has FDA decided for it lately?

  • K221344nView s1 with nav optionNview Medical · 2022
  • K211064nView s1 with nav optionNview Medical · 2021
  • K190064nView system 1Nview Medical, Inc. · 2019

All 2 as Nview Medical →The one decision as Nview Medical, Inc. →