K232617
- 510(k) number
- K232617
- Device name
- ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
- Applicant
- Siemens Medical Solutions USA, Inc. WA · US
- Product code
- IYN — System, Imaging, Pulsed Doppler, Ultrasonic
- Decision date
- 2023-09-26
- Date received
- 2023-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K232617.pdf
Official FDA record: K232617
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.