Clearance Summary
MITAYA ALUMINUM INTERSPACED X-RAY GRID received FDA 510(k) clearance under submission number K964025, sponsored by X-Ray Accessory 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 1997-06-13.
- Submission: K964025
- Applicant / Sponsor: X-Ray Accessory Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1910
- Decision date: 1997-06-13
Classification & Regulation
This clearance is catalogued under FDA product code IXJ and 21 CFR 892.1910, within the Radiology review panel as a Class I device.