Clearance Summary
KONICA LASER IMAGER LI-21 received FDA 510(k) clearance under submission number K950359, sponsored by Storch Amini & Munves PC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1995-09-06.
- Submission: K950359
- Applicant / Sponsor: Storch Amini & Munves PC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2040
- Decision date: 1995-09-06
Classification & Regulation
This clearance is catalogued under FDA product code LMC and 21 CFR 892.2040, within the Radiology review panel as a Class II device.