Clearance Summary
PLATO BRACHYTHERAPHY TREATMENT PLANNING SYSTEM received FDA 510(k) clearance under submission number K915622, sponsored by Nucletron-Oldelft 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 1992-09-25.
- Submission: K915622
- Applicant / Sponsor: Nucletron-Oldelft Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1992-09-25
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.