Clearance Summary
VPW 2877D5, X-RAY POWER SUPPLY received FDA 510(k) clearance under submission number K902106, sponsored by Varian Assoc., 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 1990-08-10.
- Submission: K902106
- Applicant / Sponsor: Varian Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1700
- Decision date: 1990-08-10
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.