Clearance Summary
3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000 received FDA 510(k) clearance under submission number K061170, sponsored by Resonance Innovations, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2006-05-25.
- Submission: K061170
- Applicant / Sponsor: Resonance Innovations, LLC
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1000
- Decision date: 2006-05-25
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.