ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System— 510(k) K152369
Substantially EquivalentSiemens Medical Solutions USA, Inc. Ultrasound Group
FDA 510(k) clearance K152369 for ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System, Substantially Equivalent on 2015-10-06. Applicant: Siemens Medical Solutions USA, Inc. Ultrasound Group. Device class: 2.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc. Ultrasound Group
- 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
- Moutain View, CA, US
Recent devices under product code IYN
view all- K261585 — Diagnostic Ultrasound System (Nuewa A20W) +10 more
- 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
More clearances from Siemens Medical Solutions USA, Inc. Ultrasound Group
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.