K233613
- 510(k) number
- K233613
- Device name
- ACUSON SC2000 Diagnostic Ultrasound System
- Applicant
- Siemens Medical Solutions USA, Inc. WA · US
- Product code
- IYO — System, Imaging, Pulsed Echo, Ultrasonic
- Decision date
- 2024-06-12
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.3 MB · U.S. public domain
Also available from FDA: K233613.pdf
Official FDA record: K233613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.