Company · US
Omega Medical Imaging, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 2025. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 6, 2025 | K242488 | Soteria E-View Omega Medical Imaging, LLC | JAA |
| Dec 13, 2021 | K212890 | Nyquist.IQ Omega Medical Imaging, LLC | JAA |
| Nov 17, 2021 | K212336 | Soteria.AI Omega Medical Imaging, LLC | OWB |
| Oct 4, 2019 | K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) Omega Medical Imaging, LLC | JAA |
| Mar 29, 2019 | K182834 | CS-series-FP with Optional ROI Accessory CA-100S Omega Medical Imaging, LLC | JAA |
| Feb 9, 2018 | K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System Omega Medical Imaging, LLC | OWB |
| Jul 26, 2012 | K121293 | CS-SERIES-FP WITH 3030+OPTION Omega Medical Imaging, LLC | JAA |
| Aug 31, 2010 | K100102 | CS-SERIES-FP Omega Medical Imaging, Inc. | OWB |
| Feb 3, 2010 | K093572 | R650 QDASM COLLIMATOR Omega Medical Imaging, Inc. | IZW |
| May 18, 2007 | K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) Omega Medical Imaging, Inc. | OWB |
| Oct 20, 2006 | K062647 | E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 Omega Medical Imaging, Inc. | OWB |
| Jan 31, 2005 | K050092 | R605 FACS COLLIMETER Omega Medical Imaging, Inc. | IZW |
| Feb 2, 1999 | K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 Omega Medical Imaging, Inc. | JAA |
| May 14, 1997 | K970947 | B-350 CEILING MOUNTED C-POSITIONER Omega Medical Imaging, Inc. | JAA |
| Sep 20, 1990 | K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE Omega Medical Imaging, Inc. | JAA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2023 | Omega Medical Imaging, Inc. Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 Open, Classified |
IWE | None listed |
| Oct 24, 2023 | Omega Medical Imaging, Inc. Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 Open, Classified |
IWE | None listed |
| Jun 19, 2017 | Omega Medical Imaging, Inc. Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory
Device accessory that elevates monitor for healthcare professionals. Terminated |
IWE | None listed |
| Jun 21, 2016 | Omega Medical Imaging, Inc. 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems. Terminated |
N/A | None listed |