Clearance Summary
CARDIAC SCANNER AND PROCESSING SYSTEM received FDA 510(k) clearance under submission number K110507, sponsored by Spectrum Dynamics (Israel) , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-07-13.
- Submission: K110507
- Applicant / Sponsor: Spectrum Dynamics (Israel) , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2011-07-13
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.