Clearance Summary
KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR received FDA 510(k) clearance under submission number K950358, 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 1995-03-17.
- Submission: K950358
- Applicant / Sponsor: Storch Amini & Munves PC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1995-03-17
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.