Clearance Summary
INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V received FDA 510(k) clearance under submission number K112054, sponsored by Toshiba Medical Systems Corporation, Japan. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2011-08-05.
- Submission: K112054
- Applicant / Sponsor: Toshiba Medical Systems Corporation, Japan
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2011-08-05
Classification & Regulation
This clearance is catalogued under FDA product code JAA and 21 CFR 892.1650, within the Radiology review panel as a Class II device.