FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartGrid
K Number: K163157
·
Decision Mar 21, 2017
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
422
Applicant Total
5
Review Days
131
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Basic Information
- Device Name
- SmartGrid
- K Number
- K163157
- 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
- November 10, 2016
- Decision Date
- March 21, 2017
- Product Code
- MQB
- 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 |
|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | FDA class 2 | Radiology |
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Other Clearances by Carestream Health
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|---|---|---|---|
| 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 |
| K213568 | DRX-Rise Mobile X-ray System | Mar 23, 2022 | Substantially Equivalent |
| K203159 | Lux 35 Detector | Dec 2, 2020 | Substantially Equivalent |