Omega Medical Imaging, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 15
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0160-2024 | Class II | Omega Medical Imaging Elevating Monitor Suspension Systems, Part Number 1000-0085 | September 8, 2023 |
| Z-0156-2024 | Class II | Omega Medical Imaging Elevating Monitor Suspension, Part Number 1000-0085 | February 28, 2023 |
| Z-2621-2017 | Class II | Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory Device ac | March 23, 2017 |
| Z-2734-2016 | Class II | 2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Sys | June 21, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K242488 | Soteria E-View | January 6, 2025 |
| K212890 | Nyquist.IQ | December 13, 2021 |
| K212336 | Soteria.AI | November 17, 2021 |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly | October 4, 2019 |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | March 29, 2019 |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | February 9, 2018 |
| K121293 | CS-SERIES-FP WITH 3030+OPTION | July 26, 2012 |
| K100102 | CS-SERIES-FP | August 31, 2010 |
| K093572 | R650 QDASM COLLIMATOR | February 3, 2010 |
| K070834 | CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS) | May 18, 2007 |
| K062647 | E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50 | October 20, 2006 |
| K050092 | R605 FACS COLLIMETER | January 31, 2005 |
| K990055 | B-400 CEILING MOUNTED POSSITIONER, MODEL B-400 | February 2, 1999 |
| K970947 | B-350 CEILING MOUNTED C-POSITIONER | May 14, 1997 |
| K902005 | MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE | September 20, 1990 |