Clearance Summary
TXR 325 X-RAY CONTROL WITH HIGH VOLTAGE GENERATOR received FDA 510(k) clearance under submission number K860203, 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 1986-01-30.
- Submission: K860203
- Applicant / Sponsor: Tingle X-Ray Products, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1986-01-30
Classification & Regulation
This clearance is catalogued under FDA product code IZO and 21 CFR 892.1700, within the Radiology review panel as a Class I device.