Clearance Summary
ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems received FDA 510(k) clearance under submission number K172162, sponsored by Siemens Healthcare. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2017-08-16.
- Submission: K172162
- Applicant / Sponsor: Siemens Healthcare
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2017-08-16
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.