ISITE PACS, V 4. X
FDA 510(k) clearance K063267 · decided 2006-11-09
Clearance details
- K-number
- K063267
- Device name
- ISITE PACS, V 4. X
- Applicant
- Stentor Inc., A Philips Medical Systems Co.
- Decision
- Substantially Equivalent
- Date received
- 2006-10-30
- Decision date
- 2006-11-09
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Brisbane, CA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| iSite PACS with Advanced Visualization Tools (AVT) R7.4V6L1, Versions: 3.6.87, 3.6.92, 4.1 recall (Z-1881-2011) | Philips Medical Systems | 2011-04-04 |
| iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and includin recall (Z-0948-2009) | Philips Healthcare Informatics, Inc. | 2009-01-30 |
| iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4. recall (Z-0118-2009) | Philips Healthcare Informatics, Inc. | 2008-10-28 |
| Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version recall (Z-1444-2008) | Philips Healthcare Informatics, Inc. | 2008-08-16 |