ACUSON Sequoia Diagnostic Ultrasound System +3 more— 510(k) K260844
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K260844 for ACUSON Sequoia Diagnostic Ultrasound System +3 more, Substantially Equivalent on 2026-06-16. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
Siemens Medical Solutions USA's clearance covers four ACUSON diagnostic ultrasound systems: Sequoia, Sequoia Select, Origin, and Origin ICE. They're filed under IYN, pulsed Doppler ultrasonic imaging systems, and the record doesn't say what "ICE" refers to.
Class II, 21 CFR 892.1550. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Siemens filed from Issaquah, Washington. The decision came 92 calendar days after receipt (March 16 to June 16, 2026).
Clearance details
- Device name as filed
- ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Product code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Issaquah, WA, US
Recent devices under product code IYN
view all- K261617 — Diagnostic Ultrasound System (11+ models)
- K263150 — V10 Diagnostic Ultrasound System +10 more
- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K263182 — EVO X30 Diagnostic Ultrasound System +8 more
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.