DRX-Evolution with Carestream Digital Tomosynthesis
510(k) K191879
DRX-Evolution with Carestream Digital Tomosynthesis is a Class II device made by Carestream Health, Inc., cleared under FDA 510(k) K191879 on 20 Dec 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191879 | Date20 Dec 2019 | StatusActive |
Official records
- FDA 510(k) database K191879
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPR
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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