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Omega Medical Imaging, LLC

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

Total Devices6
Categories2
Latest Approval2025-01-06
TypeNumberDevice NameCodeDate
510(k) K242488 Soteria E-View JAA 2025-01-06 View
510(k) K212890 Nyquist.IQ JAA 2021-12-13 View
510(k) K212336 Soteria.AI OWB 2021-11-17 View
510(k) K191713 CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) JAA 2019-10-04 View
510(k) K182834 CS-series-FP with Optional ROI Accessory CA-100S JAA 2019-03-29 View
510(k) K171755 CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System OWB 2018-02-09 View