Clearance Summary
GEM OPTION FOR 1.5 MRI SYSTEMS received FDA 510(k) clearance under submission number K103335, sponsored by GE Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-03-07.
- Submission: K103335
- Applicant / Sponsor: GE Healthcare
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2011-03-07
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.