Clearance Summary
ACUSON X300 ULTRASOUND SYSTEM received FDA 510(k) clearance under submission number K080760, sponsored by Siemens Medical Solutions USA, Inc., Ultrasound DI. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2008-04-25.
- Submission: K080760
- Applicant / Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound DI
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1550
- Decision date: 2008-04-25
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.