510(k) K192835
K192835 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System". The FDA issued a decision of Substantially Equivalent on Oct 22, 2019. 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. has 783 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 22, 2019
- Date Received
- Oct 2, 2019
- 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)