Clearance Summary
BR 2002 X-RAY GENERATOR SYSTEM received FDA 510(k) clearance under submission number K801808, sponsored by Valmet Indus. Mach. & Prod., 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 1980-09-26.
- Submission: K801808
- Applicant / Sponsor: Valmet Indus. Mach. & Prod., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1980-09-26
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.