510(k) Report

FDA applicant

Oec-Diasonics, Inc.

Salt Lake City, UT8 decisions1985–19932 recalls

FDA records 8 decisions for Oec-Diasonics, Inc. (Salt Lake City, UT) from 1985 to 1993: 8 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and KQS (Table, Cystometric, Non-Electric And Accessories). 2 recalls are 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 Oec-Diasonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Oec-Diasonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Oec-Diasonics, Inc. 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?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified5decisions
  • KQSTable, Cystometric, Non-Electric And Accessories1decision
  • IXRTable, Radiographic, Tilting1decision
  • OXOImage-Intensified Fluoroscopic X-Ray System, Mobile1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K9260569600 Fluoroscopic Imaging SystemOec-Diasonics, Inc. · 19931cites it

What has FDA decided for it lately?

  • K9260569600 Fluoroscopic Imaging SystemOec-Diasonics, Inc. · 1993
  • K924879EP 3000Oec-Diasonics, Inc. · 1993
  • K914446Uroview 2000, ModificationOec-Diasonics, Inc. · 19922 recalls
  • K896583F.a.S.T. TableOec-Diasonics, Inc. · 1990
  • K893475Uroview IIOec-Diasonics, Inc. · 19891 recall
  • K872022UroviewOec-Diasonics, Inc. · 1987
  • K864837Modified Mainframe of Model 902 Mobile C-ArmOec-Diasonics, Inc. · 1987
  • K843972Angioplus-SOec-Diasonics, Inc. · 1985

All 8 as Oec-Diasonics, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K893475Uroview 2000 X-ray SystemMay 12, 2003
  • K914446Uroview 2500 X-ray SystemMay 12, 2003