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 Number: 1052701
• FEI Number: 1000222289
• Name: OMEGA MEDICAL IMAGING, LLC
• Owner & Operator: OMEGA MEDICAL IMAGING, LLC
• Contact Address: 3400 St. Johns Parkway, Suite 1020 --; Sanford FL 32771 US
• Official Correspondent:
  • Brian - Fleming
  • x-407-3239400-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3400 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	Device	Date
GUDID 00853901007032 OMEGA MEDICAL IMAGING, LLC	Nyquist.IQ	2022-03-25
GUDID 00853901007025 OMEGA MEDICAL IMAGING, LLC	Omega Medical Imaging, LLC	2022-01-26
PMN K212336 Omega Medical Imaging, LLC	Soteria.AI	2021-11-17
GUDID 00853901007001 OMEGA MEDICAL IMAGING, LLC	Omega Medical Imaging	2020-01-13
PMN K191713 | OWB OMEGA MEDICAL IMAGING, LLC	CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield? (ROI Assembly)	2019-10-18
PMN K191713 | JAA OMEGA MEDICAL IMAGING, LLC	CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield? (ROI Assembly)	2019-10-18
PMN K182834 | OWB OMEGA MEDICAL IMAGING, LLC	CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)	2019-10-18
PMN K182834 | JAA OMEGA MEDICAL IMAGING, LLC	CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)	2019-10-18
PMN K191713 Omega Medical Imaging, LLC	CS-series-FP Radiographic / Fluoroscopic Systems With Optional CA-100S / FluoroShield™ (ROI Assembly)	2019-10-04
GUDID 00853901007018 OMEGA MEDICAL IMAGING, LLC	Omega Medical Imaging, LLC	2019-08-27
PMN K182834 Omega Medical Imaging, LLC	CS-series-FP With Optional ROI Accessory CA-100S	2019-03-29
PMN K171755 | OWB OMEGA MEDICAL IMAGING, LLC	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system	2018-12-19
PMN K171755 | JAA OMEGA MEDICAL IMAGING, LLC	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option radiographic/fluoroscopy system	2018-12-19
PMN K171755 Omega Medical Imaging, LLC	CS-series-FP With MX CFP 3131 Or MX CFP 2222 Option Radiographic/Fluoroscopy System	2018-02-09
PMN K100102 | OWB OMEGA MEDICAL IMAGING, LLC	CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)	2013-06-20
PMN K100102 | MQB OMEGA MEDICAL IMAGING, LLC	CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)	2013-06-20
PMN K100102 | JAA OMEGA MEDICAL IMAGING, LLC	CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector)	2013-06-20
PMN K093572 | IZW OMEGA MEDICAL IMAGING, LLC	R650 QDASM Beam Limiting Device	2013-06-20
PMN K121293 OMEGA MEDICAL IMAGING, LLC	CS-SERIES-FP WITH 3030+OPTION	2012-07-26
PMN K970947 | JAA OMEGA MEDICAL IMAGING, LLC	ystem, x-ray, fluoroscopic, image-intensified	2007-10-15
PMN K934574 | IXR OMEGA MEDICAL IMAGING, LLC	able, radiographic, tilting	2007-10-15
PMN K902005 | JAA OMEGA MEDICAL IMAGING, LLC	System, x-ray, fluoroscopic, image-intensified	2007-10-15
PMN K070834 | OWB OMEGA MEDICAL IMAGING, LLC	ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system	2007-10-15
PMN K070834 | JAA OMEGA MEDICAL IMAGING, LLC	ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system	2007-10-15

Related Finance Registrations

NCAGE Code	4SM84	OMEGA MEDICAL IMAGING, LLC
CAGE Code	4SM84	OMEGA MEDICAL IMAGING, LLC
S.A.M. Registration	4SM84 [622534493]	OMEGA MEDICAL IMAGING, LLC