Clearance Summary
RADREX-I, SW V4.00 MODEL DRAD-3000E received FDA 510(k) clearance under submission number K122842, sponsored by Toshiba America Medical Systems, In.C. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-10-09.
- Submission: K122842
- Applicant / Sponsor: Toshiba America Medical Systems, In.C
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2012-10-09
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.