SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System— 510(k) K162045
Substantially EquivalentFUJIFILM Sonosite, Inc.
FDA 510(k) clearance K162045 for SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System, Substantially Equivalent on 2016-08-18. Applicant: FUJIFILM Sonosite, Inc.. Device class: 2.
Clearance details
- Applicant
- FUJIFILM Sonosite, 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
- Bothell, WA, US
Recent devices under product code IYN
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- K262548 — EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
More clearances from FUJIFILM Sonosite, 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.