Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1052701

FEI Number

1000222289

Entity Name

OMEGA MEDICAL IMAGING, LLC

City/State/Country

Sanford, FL, US

Establishment Address

3400 St. Johns Parkway, Suite 1020, Sanford, FL 32771, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

OMEGA MEDICAL IMAGING, LLC (Owner Number: 9000656)

Owner / Operator Contact Address

3400 St. Johns Parkway, Suite 1020, --, Sanford, FL 32771, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182834

PMA Number

N/A

All Registered Proprietary Names

CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector) ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system Soteria Eview CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-10-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-10-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2013-06-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2013-06-20
MQB	Solid State X-Ray Imager (Flat Panel/Digital Imager)	Radiology	Class 2	892.1680	2013-06-20
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2007-10-15
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2007-10-15
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-09-05
QHY	Solid State Fluoroscopic X-Ray Imager	Radiology	Class 2	892.1650	2025-09-05
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2019-10-18
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2019-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OMEGA MEDICAL IMAGING, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K863853	Superior Medical Products	EAZY COVERS	1987-03-06
K953974	Medivision Medical Imaging, Ltd.	CAMVISION 1000	1996-09-09
K024012	Ge Oec Medical Systems	OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM	2003-03-20
K970608	Guidant Cardiac and Vascular Surgery	EVT MARKER BOARD	1997-04-21
K203010	Apelem-Dms Group	Platinum dRF Imaging System	2021-01-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2007	GE OEC Medical Systems, Inc	2	GE 4 inch Anterior Cervical Post, GE Part Number 1006385 or 1006385-NAV, GE Healthcare OEC Medical Systems (an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems)
Z-0001-2009	Philips Medical Systems North America Co. Phillips	2	NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
Z-0004-2010	Ge Healthcare	2	GE OEC 9900 Elite ESP To produce mobile fluoroscopic images of human anatomy.
Z-0005-2010	Ge Healthcare	2	GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy.
Z-0009-04	Siemens Medical Solutions USA, Inc	2	Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive

Similar Registrations

Registration Number	Establishment Name	Location
1000221974	DMX IMAGING, LLC	Palm Harbor, FL, US
3042175844	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	BEST Noord-Brabant, NL
3027373189	LIBERTY GLOBAL, LLC	Scottsdale, AZ, US
3033527282	Philips India Limited - Image Guided Therapy Systems Business Unit	Bengaluru Karnataka, IN
9614698	CANON INC.	OTAWARA-SHI Tochigi, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1052701. Last updated year: 2026. Please use registration number 1052701 when referencing this establishment in official correspondence.