Clearance Summary
CSMC Cardiac Suite received FDA 510(k) clearance under submission number K172609, sponsored by Cedars-Sinai Medical Center. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-11-03.
- Submission: K172609
- Applicant / Sponsor: Cedars-Sinai Medical Center
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2017-11-03
Classification & Regulation
This clearance is catalogued under FDA product code KPS and 21 CFR 892.1200, within the Radiology review panel as a Class II device.