Clearance Summary
MULTIDOS, QC6PLUS received FDA 510(k) clearance under submission number K972211, sponsored by Ptw-New York Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1997-09-10.
- Submission: K972211
- Applicant / Sponsor: Ptw-New York Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1997-09-10
Classification & Regulation
This clearance is catalogued under FDA product code LHN and 21 CFR 892.5050, within the Radiology review panel as a Class II device.