Clearance Summary
TABLE,RADIOGRAPHIC-FLUOROSCOPIC,TOMOGRAPHIC,REMOTE received FDA 510(k) clearance under submission number K854486, sponsored by Absolute X-Ray 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 1986-01-10.
- Submission: K854486
- Applicant / Sponsor: Absolute X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1986-01-10
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.