K241505
- 510(k) number
- K241505
- Device name
- DRX-Revolution Mobile X-ray System
- Applicant
- Carestream Health, Inc. NY · US
- Product code
- IZL — System, X-Ray, Mobile
- Decision date
- 2024-12-10
- Date received
- 2024-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241505.pdf
Official FDA record: K241505
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.