Clearance Summary
CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS received FDA 510(k) clearance under submission number K071396, sponsored by Capintec, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-06-28.
- Submission: K071396
- Applicant / Sponsor: Capintec, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1360
- Decision date: 2007-06-28
Classification & Regulation
This clearance is catalogued under FDA product code KPT and 21 CFR 892.1360, within the Radiology review panel as a Class II device.