Devices · Siemens Medical Solutions, USA, Inc.
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System
Siemens Medical Solutions, USA, Inc. is listed for ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System (K240704). The FDA list gives July 22, 2024 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K240704
- Date of final decision
- July 22, 2024
- Company on the FDA list
- Siemens Medical Solutions, USA, Inc.
- Lead panel
- Radiology
- Primary product code
- IYN
- openFDA device name for the code
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device class
- 2
- Regulation number
- 892.1550
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary