Clearance Summary
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX received FDA 510(k) clearance under submission number K091628, sponsored by Protec GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2009-08-21.
- Submission: K091628
- Applicant / Sponsor: Protec GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 2009-08-21
Classification & Regulation
This clearance is catalogued under FDA product code IXW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.