Clearance Summary
Q-Rad Radiographic System with Auto-Tracker Option received FDA 510(k) clearance under submission number K151924, sponsored by Quantum Medical Imaging Divison of Carestream. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-08-07.
- Submission: K151924
- Applicant / Sponsor: Quantum Medical Imaging Divison of Carestream
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2015-08-07
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.