Clearance Summary
CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2 received FDA 510(k) clearance under submission number K053062, sponsored by Cardiarc , 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 2006-01-06.
- Submission: K053062
- Applicant / Sponsor: Cardiarc , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1200
- Decision date: 2006-01-06
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.