Clearance Summary
RADIOGRAPHIC ITT TABLE received FDA 510(k) clearance under submission number K963905, sponsored by X-Ray Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1996-11-12.
- Submission: K963905
- Applicant / Sponsor: X-Ray Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1996-11-12
Classification & Regulation
This clearance is catalogued under FDA product code KXJ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.