Clearance Summary
PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL received FDA 510(k) clearance under submission number K140998, sponsored by Quality Electrodynamics, 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 2014-07-11.
- Submission: K140998
- Applicant / Sponsor: Quality Electrodynamics, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2014-07-11
Classification & Regulation
This clearance is catalogued under FDA product code MOS and 21 CFR 892.1000, within the Radiology review panel as a Class II device.