DRX-Rise Mobile X-ray System— 510(k) K213568
Substantially EquivalentCarestream Health
FDA 510(k) clearance K213568 for DRX-Rise Mobile X-ray System, Substantially Equivalent on 2022-03-23. Applicant: Carestream Health.
Clearance details
- Applicant
- Carestream Health
- Product code
- Code IZL
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Adverse events under product code IZL
product code IZL- Other
- 3
- Total
- 3
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.