Clearance Summary
X-RAY TUBESTANDS BUCKY STANDS & VETERINARY X-RAY received FDA 510(k) clearance under submission number K844337, sponsored by Quality X-Ray Manufacturing, 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 1985-02-21.
- Submission: K844337
- Applicant / Sponsor: Quality X-Ray Manufacturing, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1770
- Decision date: 1985-02-21
Classification & Regulation
This clearance is catalogued under FDA product code IYB and 21 CFR 892.1770, within the Radiology review panel as a Class I device.