510(k) K232617 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System
| Applicant | Siemens Medical Solutions USA, Inc., Issaquah WA, US |
| Decision | Substantially Equivalent, Sep 26, 2023 |
| Received | Aug 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232617
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software.
ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software Open, Classified |
IYN | None listed |
| Apr 19, 2024 | Siemens Medical Solutions USA, Inc. ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VA10A Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.