CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System— 510(k) K162329
Substantially EquivalentPhilips Health Care
FDA 510(k) clearance K162329 for CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Substantially Equivalent on 2016-09-14. Applicant: Philips Health Care.
Clearance details
- Applicant
- Philips Health Care
- 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.