Clearance Summary
ANATECH X-RAY GENERATOR received FDA 510(k) clearance under submission number K904114, sponsored by Continental 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 1991-01-03.
- Submission: K904114
- Applicant / Sponsor: Continental X-Ray Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1991-01-03
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.