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Omega Medical Imaging, LLC

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories2
Latest FDA decision2025-01-06
TypeNumberDevice NameCodeDateActions
510(k) K242488 Soteria E-ViewJAA2025-01-06 View
510(k) K212890 Nyquist.IQJAA2021-12-13 View
510(k) K212336 Soteria.AIOWB2021-11-17 View
510(k) K191713 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)JAA2019-10-04 View
510(k) K182834 CS-series-FP with Optional ROI Accessory CA-100SJAA2019-03-29 View
510(k) K171755 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy SystemOWB2018-02-09 View
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