Clearance Summary
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304 received FDA 510(k) clearance under submission number K010417, sponsored by Nuclear Assoc., Div. Inovision LP. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-04-26.
- Submission: K010417
- Applicant / Sponsor: Nuclear Assoc., Div. Inovision LP
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1360
- Decision date: 2001-04-26
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.