Clearance Summary
OEC 9900 ELITE received FDA 510(k) clearance under submission number K120613, sponsored by Ge Healthcare Surgery GE Oec Medical Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-04-06.
- Submission: K120613
- Applicant / Sponsor: Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2012-04-06
Classification & Regulation
This clearance is catalogued under FDA product code OXO and 21 CFR 892.1650, within the Radiology review panel as a Class II device.