510(k) K163635
K163635 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. Ultrasound Group for the device "ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems". The FDA issued a decision of Substantially Equivalent on Jan 12, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc. Ultrasound Group has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 12, 2017
- Date Received
- Dec 22, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type
- 510(k)