Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert— 510(k) K213642
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K213642 for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert, Substantially Equivalent on 2022-01-13. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- 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
- Wauwatosa, WI, US
Recent devices under product code IYN
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- K261933 — Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
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More clearances from GE Healthcare
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.