Clearance Summary
3.0T GEM RT Open Array received FDA 510(k) clearance under submission number K143389, sponsored by Ge Healthcare Coils (Usa Instruments, Inc.). The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-03-06.
- Submission: K143389
- Applicant / Sponsor: Ge Healthcare Coils (Usa Instruments, Inc.)
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2015-03-06
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.