WEB1000
FDA 510(k) clearance K053458 · decided 2005-12-22
Clearance details
- K-number
- K053458
- Device name
- WEB1000
- Applicant
- Agfa Corp.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-13
- Decision date
- 2005-12-22
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waterloo, Ontario, CA
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IMPAX 4.1, IMPAX 4.5, IMPAX 5.0, IMPAX 5.1 IMPAX 5.2, IMPAX 6.0, IMPAX 6.2; Picture Archiv recall (Z-1243-2008) | AGFA Corp. | 2008-09-11 |
| WEB1000 Versions 3.1, 4.1 and 5.1, Picture Archiving and Communications systems (PACs), us recall (Z-1244-2008) | AGFA Corp. | 2008-09-11 |