Impax Client Embrace
by Agfa Corp.
510(k) K040555
Impax Client Embrace is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Agfa Corp., cleared under FDA 510(k) K040555 on 26 May 2004, active as of 22 Oct 2026. 3 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 | NumberK040555 | Date26 May 2004 | StatusActive |
Official records
- FDA 510(k) database K040555
Recalls
-
- Terminated Z-1245-2008
Text and Images may not be synchronized.
-
- 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) K040555
- Recall initiated FDA recalls Z-1244-2008
- Recall initiated FDA recalls Z-1243-2008
- Recall initiated FDA recalls Z-1245-2008
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- Withdrawn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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