Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System— 510(k) K212704
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K212704 for Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System, Substantially Equivalent on 2021-09-24. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- 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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More clearances from Philips Medical Systems
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- K192875 — Philips Biosensor BX100
- K183387 — M3290B Patient Information Center iX
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.