Soteria E-View
Omega Medical Imaging, LLC
OMEGA MEDICAL IMAGING, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1052701 | 1000222289 | OMEGA MEDICAL IMAGING, LLC | 1 | N | 2026-01-01 | 3400 St. Johns Parkway, Suite 1020 Sanford FL US 32771 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 70388 | 1656778242 | K970947 | B-350 CEILING MOUNTED C-POSITIONER | JAA | 1997-05-14 |
| 70388 | 1843995035 | K934574 | MODEL MPFT-01, GENESIS | IXR | 1994-03-04 |
| 70388 | 1253654022 | K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | JAA | 1990-09-20 |
| 70388 | 1259156987 | K242488 | Soteria E-View | JAA | 2025-01-06 |
| 70388 | 1370021683 | K212890 | Nyquist.IQ | JAA | 2021-12-13 |
| 70388 | 1166455892 | K212336 | Soteria.AI | OWB | 2021-11-17 |
| 70388 | 1206972607 | K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) | JAA | 2019-10-04 |
| 70388 | 1939181068 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | JAA | 2019-03-29 |
| 70388 | 1486819605 | K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | OWB | 2018-02-09 |
| 70388 | 1018668148 | K100102 | CS-SERIES-FP | OWB | 2010-08-31 |
| 70388 | 1608247407 | K093572 | R650 QDASM COLLIMATOR | IZW | 2010-02-03 |
| 70388 | 1990919807 | K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | OWB | 2007-05-18 |
Product Codes Associated With Registrations#
PMN#
Nyquist.IQ
Omega Medical Imaging, LLC
Soteria.AI
Omega Medical Imaging, LLC
CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly)
Omega Medical Imaging, LLC
CS-series-FP With Optional ROI Accessory CA-100S
Omega Medical Imaging, LLC
CS-series-FP With MX CFP 3131 Or MX CFP 2222 Option Radiographic/Fluoroscopy System
Omega Medical Imaging, LLC
CS-SERIES-FP WITH 3030+OPTION
OMEGA MEDICAL IMAGING, LLC
CS-SERIES-FP
OMEGA MEDICAL IMAGING, INC.
R650 QDASM COLLIMATOR
OMEGA MEDICAL IMAGING, INC.
CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)
OMEGA MEDICAL IMAGING, INC.
E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50
OMEGA MEDICAL IMAGING, INC.
R605 FACS COLLIMETER
OMEGA MEDICAL IMAGING, INC.
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
OMEGA MEDICAL IMAGING, INC.
B-350 CEILING MOUNTED C-POSITIONER
OMEGA MEDICAL IMAGING, INC.
MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE
OMEGA MEDICAL IMAGING, INC.
GUDID#
Omega Medical Imaging, LLC - CS-series-FP is a Complete System Flat Panel fluoroscopic Imaging System consisting of a patient table, C-arm positioner, X-ray tube, X-ray generator, Flat Panel Detector and Image Processor. The system is configurable with selectable components i.e. tubes, generators, tables, c-arms and flat panel detectors per customer requirements.
2019-08-19
Soteria Eview - Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
2025-10-03
Nyquist.IQ - Digital Medical Image Processor
2022-03-17
Omega Medical Imaging, LLC - Interventional Imaging System consisting of a C-Arm, Patient Table, High Voltage Generator, X-Ray Tube, Flat Panel Detector and Image Processor.
2022-01-18
Omega Medical Imaging - CS50 is a Complete System 50 eVIEW Fluoroscopic Imaging system. The Patient table, Positioner, X-Ray tube, Image Receptor and Image processor are configurable with interchangeable components that are customer specific resulting in a unit configuration i.e. CS50-P2-G2-T3-I4-A4.
2017-05-04