Devices · Omega Medical Imaging, LLC
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
Omega Medical Imaging, LLC is listed for CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) (K191713). The FDA list gives October 4, 2019 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JAA. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191713
- Date of final decision
- October 4, 2019
- Company on the FDA list
- Omega Medical Imaging, LLC
- Lead panel
- Radiology
- Primary product code
- JAA
- openFDA device name for the code
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device class
- 2
- Regulation number
- 892.1650
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary