EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System— 510(k) K211597
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K211597 for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, Substantially Equivalent on 2021-09-08. Applicant: Philips Medical Systems.
Clearance details
- Applicant
- Philips Medical Systems
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bothell, WA, US
Adverse 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.