Clearance Summary
MD100 & MM150 received FDA 510(k) clearance under submission number K963913, sponsored by Konica Medical 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 1997-10-08.
- Submission: K963913
- Applicant / Sponsor: Konica Medical Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1960
- Decision date: 1997-10-08
Classification & Regulation
This clearance is catalogued under FDA product code EAM and 21 CFR 892.1960, within the Radiology review panel as a Class I device.