DOSERIGHT— 510(k) K012238
Substantially EquivalentPhilips Medical Systems North America Co.
FDA 510(k) clearance K012238 for DOSERIGHT, Substantially Equivalent on 2001-10-01. Applicant: Philips Medical Systems North America Co..
Clearance details
- Applicant
- Philips Medical Systems North America Co.
- Product code
- Code JAK
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.