Clearance Summary
525 SFQ X-RAY CONTROL W/HIGH VOLTAGE GENERATOR received FDA 510(k) clearance under submission number K926554, sponsored by Tingle 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 1993-05-17.
- Submission: K926554
- Applicant / Sponsor: Tingle X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 1993-05-17
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.