Clearance Summary
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System received FDA 510(k) clearance under submission number K171755, sponsored by Omega Medical Imaging, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2018-02-09.
- Submission: K171755
- Applicant / Sponsor: Omega Medical Imaging, LLC
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2018-02-09
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.