ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System— 510(k) K223735
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K223735 for ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, Substantially Equivalent on 2023-02-06. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Issaquah, WA, US
Recent devices under product code IYN
view all- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K261668 — Venue Go
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
- K261835 — LOGIQ Focus
More clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.