Clearance Summary
ULTRASOUND SCANNER MODEL #1150 received FDA 510(k) clearance under submission number K900469, sponsored by Pie Medical USA BV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-07-09.
- Submission: K900469
- Applicant / Sponsor: Pie Medical USA BV
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1560
- Decision date: 1990-07-09
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.