Clearance Summary
AMCAD-UT DETECTION MODEL 2.0 received FDA 510(k) clearance under submission number K122536, sponsored by Lin & Associates, 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 2013-10-03.
- Submission: K122536
- Applicant / Sponsor: Lin & Associates, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2013-10-03
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.