Known Identifiers & Locations
FEI Numbers
3001236302
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (3)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0031-2007 |
CR DX-S, Image Intensified Fluoroscopic X-ray system.
Reason: Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
|
2006-06-28 |
Terminated
|
View Details
|
| Z-0033-2007 |
IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)
Reason: Failed CAD displayed as 'No Findings'
|
2006-08-08 |
Terminated
|
View Details
|
| Z-0035-2014 |
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Reason: System downtime and/or slow performance may result if software in use is an old version of IMPAX and is not at current supported levels.
|
2013-09-19 |
Terminated
|
View Details
|
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.