Data / Medical devices / United States / Omega Medical Imaging, LLC
Omega Medical Imaging, LLC: FDA-registered device maker in Sanford, FL, United States, 7 510(k) clearances
Omega Medical Imaging, LLC is registered with the FDA (registration 1052701) in Sanford, FL, United States. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 6, 2025. 4 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1052701
- FEI number
- 1000222289
- Address
- 3400 St. Johns Parkway, Suite 1020, Sanford, FL, United States, 32771
- Owner or operator
- OMEGA MEDICAL IMAGING, LLC (9000656)
- Roles
- Manufacturer, Specification developer
- First device listed
- October 15, 2007
- Registered through
- 2027
- Brand names listed
- CS-series-FP Fluoroscopy System with optional Solid State X-Ray Imaging device (Flat Panel Detector), CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly), CS-series-FP Radiographic Fluoroscopy System with Optional Accessory Device CA-100S (ROI Assembly), Nyquist.IQ, Soteria Eview, Soteria.AI, ystem, x-ray, fluoroscopic, image-intensifiedInterventional fluoroscopic x-ray system
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Solid State Fluoroscopic X-Ray Imager | QHY | 2 | Manufacturer | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 6, 2025 | K242488 | Soteria E-View | JAA | Substantially Equivalent | Omega Medical Imaging, LLC | accessdata.fda.gov |
| December 13, 2021 | K212890 | Nyquist.IQ | JAA | Substantially Equivalent | Omega Medical Imaging, LLC | accessdata.fda.gov |
| November 17, 2021 | K212336 | Soteria.AI | OWB | Substantially Equivalent | Omega Medical Imaging, LLC | accessdata.fda.gov |
| October 4, 2019 | K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | JAA | Substantially Equivalent | Omega Medical Imaging, LLC | accessdata.fda.gov |
| March 29, 2019 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S | JAA | Substantially Equivalent | Omega Medical Imaging, LLC | accessdata.fda.gov |
| August 31, 2010 | K100102 | CS-SERIES-FP | OWB | Substantially Equivalent | Omega Medical Imaging, Inc. | accessdata.fda.gov |
| May 18, 2007 | K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | OWB | Substantially Equivalent | Omega Medical Imaging, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 8, 2023 | 93123 | Class II | Ongoing | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable. | accessdata.fda.gov |
| February 28, 2023 | 93018 | Class II | Ongoing | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location. | accessdata.fda.gov |
| March 23, 2017 | 77458 | Class II | Terminated | Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device accessory that elevates monitor for healthcare professionals. | Elevating Monitor Suspension column dropping and will not rise back up. | accessdata.fda.gov |
| June 21, 2016 | 74886 | Class II | Terminated | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. | Elevating Monitor Suspension separated from the lifting column bracket | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Fluoroscopic, Image-Intensified
- All makers of Interventional Fluoroscopic X-Ray System
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
Updated January 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.