Clearance Summary
CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165 received FDA 510(k) clearance under submission number K030066, sponsored by Nuclear Associates. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2003-08-29.
- Submission: K030066
- Applicant / Sponsor: Nuclear Associates
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1360
- Decision date: 2003-08-29
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.