Clearance Summary
NUCLETRON PLANNING SYSTEM received FDA 510(k) clearance under submission number K911612, 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 1991-06-13.
- Submission: K911612
- Applicant / Sponsor: Nucletron-Oldelft Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5050
- Decision date: 1991-06-13
Classification & Regulation
This clearance is catalogued under FDA product code IYE and 21 CFR 892.5050, within the Radiology review panel as a Class II device.