Omega Medical Imaging L L C

FDA Filings

This page includes the latest FDA filings for Omega Medical Imaging L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number1052701
FEI Number1000222289
NameOMEGA MEDICAL IMAGING, LLC
Owner & OperatorOMEGA MEDICAL IMAGING, LLC
Contact Address3400 St. Johns Parkway, Suite 1020 --
Sanford FL 32771 US
Official Correspondent
  • Brian - Fleming
  • x-407-3239400-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3400 B St. Johns Parkway
Sanford, FL 32771 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Omega Medical Imaging, LLC
Soteria.AI2021-11-17
OMEGA MEDICAL IMAGING, LLC
Omega Medical Imaging 2020-01-13
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield? (ROI Assembly)2019-10-18
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield? (ROI Assembly)2019-10-18
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)2019-10-18
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)2019-10-18
Omega Medical Imaging, LLC
CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly)2019-10-04
OMEGA MEDICAL IMAGING, LLC
Omega Medical Imaging, LLC 2019-08-27
Omega Medical Imaging, LLC
CS-series-FP With Optional ROI Accessory CA-100S2019-03-29
OMEGA MEDICAL IMAGING, LLC
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system2018-12-19
OMEGA MEDICAL IMAGING, LLC
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system2018-12-19
Omega Medical Imaging, LLC
CS-series-FP With MX CFP 3131 Or MX CFP 2222 Option Radiographic/Fluoroscopy System2018-02-09
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)2013-06-20
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)2013-06-20
OMEGA MEDICAL IMAGING, LLC
CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)2013-06-20
OMEGA MEDICAL IMAGING, LLC
R650 QDASM Beam Limiting Device2013-06-20
OMEGA MEDICAL IMAGING, LLC
CS-SERIES-FP WITH 3030+OPTION2012-07-26
OMEGA MEDICAL IMAGING, LLC
ystem, x-ray, fluoroscopic, image-intensified2007-10-15
OMEGA MEDICAL IMAGING, LLC
able, radiographic, tilting2007-10-15
OMEGA MEDICAL IMAGING, LLC
System, x-ray, fluoroscopic, image-intensified2007-10-15
OMEGA MEDICAL IMAGING, LLC
ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system2007-10-15
OMEGA MEDICAL IMAGING, LLC
ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system2007-10-15

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