Clearance Summary
SELECTRON LDR SELECTRON LOW DOSE RATE received FDA 510(k) clearance under submission number K844714, sponsored by Radiochemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1985-02-26.
- Submission: K844714
- Applicant / Sponsor: Radiochemical Co.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 1985-02-26
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.