Clearance Summary
HIGH DOSE RATE AFTERLOADER received FDA 510(k) clearance under submission number K945383, 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 1995-02-15.
- Submission: K945383
- Applicant / Sponsor: Varian Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1995-02-15
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.