Clearance Summary
MEDICAL X-RAY FILM received FDA 510(k) clearance under submission number K860797, sponsored by India-America Trading 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 1986-03-13.
- Submission: K860797
- Applicant / Sponsor: India-America Trading Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1840
- Decision date: 1986-03-13
Classification & Regulation
This clearance is catalogued under FDA product code IWZ and 21 CFR 892.1840, within the Radiology review panel as a Class I device.