510(k) Report

FDA applicant

Infimed, Inc.

Liverpool, NY14 decisions1993–20110 recalls

FDA records 14 decisions for Infimed, Inc. (Liverpool, NY) from 1993 to 2011: 14 510(k) clearances. Most are in product codes OWB (Interventional Fluoroscopic X-Ray System) and LLZ (System, Image Processing, Radiological). Its devices cite 17 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

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 Infimed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2010: 22011: 3
2007high 3 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Infimed, Inc.’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 System6decisions
  • LLZSystem, Image Processing, Radiological2decisions
  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified1decision
  • IYEAccelerator, Linear, Medical1decision
  • EHDUnit, X-Ray, Extraoral With Timer1decision
  • MUHSystem, X-Ray, Extraoral Source, Digital1decision

Also: LMD (1), MQB (1).

Whose devices does it build on?

Its devices cite 17 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 7 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.

  • K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 20105cite it
  • K012490Orion Digital Imaging SystemInfimed, Inc. · 20024cite it
  • K992794Stingray DR, Model 1Infimed, Inc. · 19994cite it
  • K963037PatriotInfimed, Inc. · 19964cite it
  • K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 20112cite it
  • K933299QL Multipulse 2048Infimed, Inc. · 19931cites it

What has FDA decided for it lately?

  • K112180I5 Digital X-Ray Imaging System (with SDX-4336CP)Infimed, Inc. · 2011
  • K111344I5 Digital X-Ray Imaging System (with Flaatz 560)Infimed, Inc. · 2011
  • K103416Nexus DRF Digital X-Ray Imaging SystemInfimed, Inc. · 2011
  • K101833Infistitch for I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
  • K093066I5 Digital X-Ray Imaging System, Model I5Infimed, Inc. · 2010
  • K012490Orion Digital Imaging SystemInfimed, Inc. · 2002
  • K992392RTLXInfimed, Inc. · 2000
  • K992794Stingray DR, Model 1Infimed, Inc. · 1999

All 14 as Infimed, Inc. →