Clearance Summary
TILTING TABLE RADIOGRAPHIC A9006 TOMOJUPITER received FDA 510(k) clearance under submission number K850948, sponsored by D&R X-Ray Products, 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 1985-04-10.
- Submission: K850948
- Applicant / Sponsor: D&R X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1985-04-10
Classification & Regulation
This clearance is catalogued under FDA product code IXR and 21 CFR 892.1980, within the Radiology review panel as a Class II device.