Clearance Summary
HANDHELD GAMMA FINDER (HGF) received FDA 510(k) clearance under submission number K013751, sponsored by Silicon Instruments Gmhb. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-02-06.
- Submission: K013751
- Applicant / Sponsor: Silicon Instruments Gmhb
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1320
- Decision date: 2002-02-06
Classification & Regulation
This clearance is catalogued under FDA product code IZD and 21 CFR 892.1320, within the Radiology review panel as a Class I device.