Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Omega Medical Imaging, LLC · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

113 daysmedian FDA review time
241 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242488Soteria E-ViewOmega Medical Imaging, LLC2025-01-061380
K212890Nyquist.IQOmega Medical Imaging, LLC2021-12-13940
K212336Soteria.AIOmega Medical Imaging, LLC2021-11-171130
K191713CS-series-FP Radiographic / Fluoroscopic Systems with OptionOmega Medical Imaging, LLC2019-10-041000
K182834CS-series-FP with Optional ROI Accessory CA-100SOmega Medical Imaging, LLC2019-03-291710
K171755CS-series-FP with MX CFP 3131 or MX CFP 2222 Option RadiograOmega Medical Imaging, LLC2018-02-092410
K121293CS-SERIES-FP WITH 3030+OPTIONOmega Medical Imaging, LLC2012-07-26870

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda