510(k) Report

FDA applicant

Portavision Medical, LLC

Jefferson, LA6 decisions2007–20210 recalls

FDA records 6 decisions for Portavision Medical, LLC (Jefferson, LA) from 2007 to 2021: 6 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and MQB (Solid State X-Ray Imager (Flat Panel/Digital…). Since 2016 its 510(k)s took a median of 64 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Portavision Medical”.

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

FDA decisions per year

2in 2021

2007: 12008: 12014: 12019: 12021: 2
2007high 2 (2021) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Portavision Medical, LLC’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
  • MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)1decision
  • IZLSystem, X-Ray, Mobile1decision
  • IXKSystem, Imaging, X-Ray, Electrostatic1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 64 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 60 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 2 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.

  • K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 20213cite it
  • K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 20192cite it
  • K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 20211cites it

What has FDA decided for it lately?

  • K212557Virtual C DRF-NEO Digital Imaging SystemPortavision Medical, LLC · 2021
  • K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
  • K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
  • K133524Pvmed DDR 2430TPortavision Medical, LLC · 2014
  • K083048Neoray DR 2520 Digital Imaging SystemPortavision Medical, LLC · 2008
  • K072766Pvmed DDR 2520 Digital Imaging SystemPortavision Medical · 2007

All 5 as Portavision Medical, LLC →The one decision as Portavision Medical →