Dx-Si
by Agfa Corp.
510(k) K063421
Dx-Si is a Class II device made by Agfa Corp., cleared under FDA 510(k) K063421 on 22 Nov 2006, 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 | NumberK063421 | Date22 Nov 2006 | StatusActive |
Official records
- FDA 510(k) database K063421
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1680
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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