Clearance Summary
SpaceOAR System received FDA 510(k) clearance under submission number DEN140030, sponsored by Augmenix, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-04-01.
- Submission: DEN140030
- Applicant / Sponsor: Augmenix, Inc.
- Clearance pathway: Direct
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5725
- Decision date: 2015-04-01
Classification & Regulation
This clearance is catalogued under FDA product code OVB and 21 CFR 892.5725, within the Radiology review panel as a Class II device.