K233381
- 510(k) number
- K233381
- Device name
- DRX-Evolution Plus System
- Applicant
- Carestream Health, Inc. NY · US
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2024-03-12
- Date received
- 2023-10-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K233381.pdf
Official FDA record: K233381
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.