VITAL CONNECT 4.0
FDA 510(k) clearance K062154 · decided 2006-08-10
Clearance details
- K-number
- K062154
- Device name
- VITAL CONNECT 4.0
- Applicant
- Vital Images, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-28
- Decision date
- 2006-08-10
- Days to decision
- 13 days
- Clearance type
- Abbreviated
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Minnetonka, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VitreaCore software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 recall (Z-0169-2014) | Vital Images, Inc. | 2013-11-06 |
| Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX p recall (Z-1002-2013) | Vital Images, Inc. | 2013-03-27 |
| Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic softw recall (Z-1021-2011) | Vital Images, Inc. | 2011-02-02 |
| Vital Images ViTALConnect , Version 4.0 and 4.1, PET/CT Visualization option. Vital Images recall (Z-0520-2008) | Vital Images, Inc. | 2008-01-31 |