FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
K Number: K250954
·
Decision Jan 20, 2026
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
5
Review Days
298
Basic Information
- Device Name
- DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector
- K Number
- K250954
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carestream Health
- Date Received
- March 28, 2025
- Decision Date
- January 20, 2026
- Product Code
- KPR
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | FDA class 2 | Radiology |
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Other Clearances by Carestream Health
| K Number | Device Name | ||
|---|---|---|---|
| K253185 | Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System | Mar 11, 2026 | Substantially Equivalent |
| K213568 | DRX-Rise Mobile X-ray System | Mar 23, 2022 | Substantially Equivalent |
| K203159 | Lux 35 Detector | Dec 2, 2020 | Substantially Equivalent |
| K163157 | SmartGrid | Mar 21, 2017 | Substantially Equivalent |