Clearance Summary
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K121422, sponsored by Toshiba Medical Systems Coporation, 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 2012-08-16.
- Submission: K121422
- Applicant / Sponsor: Toshiba Medical Systems Coporation, Japan
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 2012-08-16
Classification & Regulation
This clearance is catalogued under FDA product code IYO and 21 CFR 892.1560, within the Radiology review panel as a Class II device.