510(k) Report

FDA applicant

Televere Systems

Arnold, MD6 decisions2006–20180 recalls

FDA records 6 decisions for Televere Systems (Arnold, MD) from 2006 to 2018: 6 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 29 days from receipt to decision, against 30 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Televere Systems, 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 Televere Systems’s devices, and how often a recall has named them.

FDA decisions per year

2in 2018

2009: 12017: 22018: 2
2007high 2 (2017) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)2decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • KPRSystem, X-Ray, Stationary1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 29 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 30 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 3 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.

  • K061035Tigerview ProfessionalTelevere Systems · 20065cite it
  • K082623Visix ImagingTelevere Systems · 20092cite it
  • K170975Televere Digital Imaging SystemTelevere Systems · 20172cite it

What has FDA decided for it lately?

  • K181358Televere Digital Dental Imaging SystemTelevere Systems, Inc. · 2018
  • K180765Televere Podiatry X-Ray System HFTelevere Systems, Inc. · 2018
  • K172124Televere Podiatry Digital Imaging SystemTelevere Systems · 2017
  • K170975Televere Digital Imaging SystemTelevere Systems · 2017
  • K082623Visix ImagingTelevere Systems · 2009
  • K061035Tigerview ProfessionalTelevere Systems · 2006

All 4 as Televere Systems →All 2 as Televere Systems, Inc. →