COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM— 510(k) K902926
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K902926 for COLOR VELOCITY IMAGING (CVI) OPTION FOR PLATINUM, Substantially Equivalent on 1990-11-26. Applicant: Philips Medical Systems North America, Inc..
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code ITX
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Ana, CA, US
Adverse events under product code ITX
product code ITX- Death
- 6
- Injury
- 137
- Malfunction
- 2,036
- Total
- 2,179
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.