WEB1000
by Agfa Corp.
510(k) K053458
WEB1000 is a Class II device made by Agfa Corp., cleared under FDA 510(k) K053458 on 22 Dec 2005, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK053458 | Date22 Dec 2005 | StatusActive |
Official records
- FDA 510(k) database K053458
Recalls
-
- Terminated Z-1244-2008
- Terminated Z-1243-2008
Java version 1.6x (JAVA 6) is not compatible with AGFA IMPAX Administration/Service Tools. Due to a Software Mismatch data can be lost.
Timeline
- Cleared FDA 510(k) K053458
- Recall initiated FDA recalls Z-1244-2008
- Recall initiated FDA recalls Z-1243-2008
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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