510(k) K172162
K172162 is an FDA 510(k) premarket notification submitted by Siemens Healthcare for the device "ACUSON S3000 S2000 S1000 Diagnostic Ultrasound Systems". The FDA issued a decision of Substantially Equivalent on Aug 16, 2017. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Healthcare has 31 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 16, 2017
- Date Received
- Jul 18, 2017
- 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)