Clearance Summary
MANUAL AND REMOTE CONTROLLED APPLICATOR SYSTEM received FDA 510(k) clearance under submission number K000081, sponsored by Isotopes and Metals , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2000-12-19.
- Submission: K000081
- Applicant / Sponsor: Isotopes and Metals , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2000-12-19
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.