Clearance Summary
INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN received FDA 510(k) clearance under submission number K111098, sponsored by Imaging Dynamics Company , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-05-27.
- Submission: K111098
- Applicant / Sponsor: Imaging Dynamics Company , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2011-05-27
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.