Clearance Summary
CASSETTE, RADIOGRAPHIC FILM received FDA 510(k) clearance under submission number K930220, sponsored by X-Ray Accessories Mfg. Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1993-04-13.
- Submission: K930220
- Applicant / Sponsor: X-Ray Accessories Mfg. Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1850
- Decision date: 1993-04-13
Classification & Regulation
This clearance is catalogued under FDA product code IXA and 21 CFR 892.1850, within the Radiology review panel as a Class II device.