FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRX-Rise Mobile X-ray System
K Number: K213568
·
Decision Mar 23, 2022
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
235
Applicant Total
5
Review Days
134
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Basic Information
- Device Name
- DRX-Rise Mobile X-ray System
- K Number
- K213568
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1720
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carestream Health
- Date Received
- November 9, 2021
- Decision Date
- March 23, 2022
- Product Code
- IZL
- 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 |
|---|---|---|---|
| IZL | System, X-Ray, Mobile | 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 |
| K250954 | DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector | Jan 20, 2026 | Substantially Equivalent |
| K203159 | Lux 35 Detector | Dec 2, 2020 | Substantially Equivalent |
| K163157 | SmartGrid | Mar 21, 2017 | Substantially Equivalent |