Clearance Summary
GAMMALOC SYSTEM, MODEL 03-00001 received FDA 510(k) clearance under submission number K082588, sponsored by Dilon Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-12-11.
- Submission: K082588
- Applicant / Sponsor: Dilon Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1100
- Decision date: 2009-12-11
Classification & Regulation
This clearance is catalogued under FDA product code IYX and 21 CFR 892.1100, within the Radiology review panel as a Class I device.