510(k) Report

FDA applicant

Omega Medical Imaging, Inc.

Sanford, FL15 decisions1990–20250 recalls

FDA records 15 decisions for Omega Medical Imaging, Inc. (Sanford, FL) from 1990 to 2025: 15 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 113 days from receipt to decision, against 54 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 12 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Omega Medical Imaging, LLC”.

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 Omega Medical Imaging, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12010: 22012: 12018: 12019: 22021: 22025: 1
2007high 2 (2010) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • JAASystem, X-Ray, Fluoroscopic, Image-Intensified8decisions
  • OWBInterventional Fluoroscopic X-Ray System5decisions
  • IZWCollimator, Automatic, Radiographic2decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 113 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 54 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 25 predicates; 12 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 12 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.

  • K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 20193cite it
  • K050092R605 Facs CollimeterOmega Medical Imaging, Inc. · 20053cite it
  • K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 20122cite it
  • K970947B-350 Ceiling Mounted C-PositionerOmega Medical Imaging, Inc. · 19971cites it
  • K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC · 20181cites it
  • K212336Soteria.AIOmega Medical Imaging, LLC · 20211cites it

What has FDA decided for it lately?

  • K242488Soteria E-ViewOmega Medical Imaging, LLC · 2025
  • K212890Nyquist.IQOmega Medical Imaging, LLC · 2021
  • K212336Soteria.AIOmega Medical Imaging, LLC · 2021
  • K191713CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)Omega Medical Imaging, LLC · 2019
  • K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC · 2019
  • K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOmega Medical Imaging, LLC · 2018
  • K121293CS-Series-FP with 3030+OptionOmega Medical Imaging, LLC · 2012
  • K100102CS-Series-FPOmega Medical Imaging, Inc. · 2010

All 8 as Omega Medical Imaging, Inc. →All 7 as Omega Medical Imaging, LLC →

Other applicant names beginning “Omega”

FDA records each applicant name separately; these may or may not be the same firm.

Omega Medical Electronics 21Omega-Med Intl., Inc. 9Omega Laboratories, Inc. 9Omega Medical Diagnostics 5Omega Silicone, Inc. 5Omega Universal Technologies, Ltd. 3Omega Surgical Instruments, Inc. 3Omega Medical Corp. 2Omega Point Systems, LLC 1Omega Mark-3 Pen Corp. 1Omega Technologies, Inc. 1Omega Critical Care Limited 1