# Omega Medical Imaging, Inc.

- Location (FDA's records): Sanford, FL
- FDA decisions: 15 (1990–2025): 15 510(k) clearances
- Names in FDA's records: Omega Medical Imaging, Inc. (8); Omega Medical Imaging, LLC (7)
- Product codes: JAA (8), OWB (5), IZW (2)
- 510(k) review time since 2016: median 113 days, against 54 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 25 (12 its own); citations of its devices by later devices: 15 (12 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Philips Medical Systems North America, Inc.: 4 (https://510kreport.com/company/philips-medical-systems-north-america)
- Siemens Medical Systems, Inc.: 2 (https://510kreport.com/company/siemens-medical-systems)
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)
- Fischer Imaging Corp.: 2 (https://510kreport.com/company/fischer-imaging)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Siemens Medical Solutions USA, Inc.: 1 (https://510kreport.com/company/siemens-medical-solutions-usa)

## Firms that cite its devices most
- Ralco S.R.L.: 2 (https://510kreport.com/company/ralco)
- Mx Imaging, Inc.: 1 (https://510kreport.com/company/mx-imaging)

## Its most-cited devices
- K182834: CS-series-FP with Optional ROI Accessory CA-100S (2019), cited by 3
- K050092: R605 Facs Collimeter (2005), cited by 3
- K121293: CS-Series-FP with 3030+Option (2012), cited by 2
- K970947: B-350 Ceiling Mounted C-Positioner (1997), cited by 1
- K171755: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (2018), cited by 1
- K212336: Soteria.AI (2021), cited by 1

## Recent decisions
- K242488: Soteria E-View (Jan 6, 2025)
- K212890: Nyquist.IQ (Dec 13, 2021)
- K212336: Soteria.AI (Nov 17, 2021)
- K191713: CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) (Oct 4, 2019)
- K182834: CS-series-FP with Optional ROI Accessory CA-100S (Mar 29, 2019)
- K171755: CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System (Feb 9, 2018)
- K121293: CS-Series-FP with 3030+Option (Jul 26, 2012)
- K100102: CS-Series-FP (Aug 31, 2010)

Source page: https://510kreport.com/company/omega-medical-imaging