FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRX-Evolution with Carestream Digital Tomosynthesis
K Number: K191879
·
Decision Dec 20, 2019
Classifications
1
FEI Numbers
81
Registration Numbers
81
Same Product Code
355
Applicant Total
48
Review Days
158
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Basic Information
- Device Name
- DRX-Evolution with Carestream Digital Tomosynthesis
- K Number
- K191879
- 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, Inc.
- Date Received
- July 15, 2019
- Decision Date
- December 20, 2019
- 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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| K192894 | Vita Flex CR System with LLI | Feb 18, 2020 | Substantially Equivalent |
| K193574 | Q-Rad System | Jan 22, 2020 | Substantially Equivalent |
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