FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Carestream DRX-Evolution
K Number: K163203
·
Decision Dec 13, 2016
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
48
Review Days
28
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Basic Information
- Device Name
- Carestream DRX-Evolution
- K Number
- K163203
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1680
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Carestream Health, Inc.
- Date Received
- November 15, 2016
- Decision Date
- December 13, 2016
- 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, Inc.
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|---|---|---|---|
| K251168 | Image Suite | Sep 4, 2025 | Substantially Equivalent |
| K241505 | DRX-Revolution Mobile X-ray System | Dec 10, 2024 | Substantially Equivalent |
| K233381 | DRX-Evolution Plus System | Mar 12, 2024 | Substantially Equivalent |
| K223842 | DRX - Compass | Jan 20, 2023 | Substantially Equivalent |
| K213307 | Eclipse II with Smart Noise Cancellation | Jan 14, 2022 | Substantially Equivalent |
| K202441 | Eclipse II with Smart Noise Cancellation | Apr 2, 2021 | Substantially Equivalent |
| K201373 | DRX-Compass | Jun 26, 2020 | Substantially Equivalent |
| K192894 | Vita Flex CR System with LLI | Feb 18, 2020 | Substantially Equivalent |
| K193574 | Q-Rad System | Jan 22, 2020 | Substantially Equivalent |
| K191879 | DRX-Evolution with Carestream Digital Tomosynthesis | Dec 20, 2019 | Substantially Equivalent |