Clearance Summary
AIDA V1.5 DIAGNOSTIC ULTRASOUND SYSTEM GM-72P00A received FDA 510(k) clearance under submission number K113612, sponsored by Panasonic Healthcare Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2012-02-10.
- Submission: K113612
- Applicant / Sponsor: Panasonic Healthcare Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2012-02-10
Classification & Regulation
This clearance is catalogued under FDA product code IYN and 21 CFR 892.1550, within the Radiology review panel as a Class II device.