Clearance Summary
XMC-S TUBESTAND XMT-S TABLE XMH-NTWALL received FDA 510(k) clearance under submission number K842094, sponsored by X-Ray Mfg. & Sales, 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 1985-05-24.
- Submission: K842094
- Applicant / Sponsor: X-Ray Mfg. & Sales, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1980
- Decision date: 1985-05-24
Classification & Regulation
This clearance is catalogued under FDA product code IXQ and 21 CFR 892.1980, within the Radiology review panel as a Class II device.