510(k) · Cleared
Recalled · Class II · 2013Vital Connect 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vital Images, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 10, 2006 as substantially equivalent to K040876 (Vital Images, Inc., 2004) after a 13-day review. Its family tree reaches back 6 generations to 1991. 12 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 10, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 20 ancestors in all, the oldest K896095 (1990). 12 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 2 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 1 generation backK040876 Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareVital Images, Inc. · 2004
- This deviceK062154 Vital Connect 4.0Vital Images, Inc. · 2006
- Descendant · cites it directly · 11 of its ownK071362 Vital Connect 4.1Vital Images, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 3 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 4 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · 5 generations on · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K071362Vital Connect 4.1Vital Images, Inc. · 2007 · cites it directly11descendants
- K150738VitreaViewVital Images, Inc. · 2015 · 2 generations on8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 3 generations on7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 4 generations on6descendants
- K213215VSI HoloMedicineApoqlar GmbH · 2022 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −2 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −1 | K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing Software | Vital Images, Inc. | 2004 | — |
| 0 (this device) | K062154 | Vital Connect 4.0 | Vital Images, Inc. | 2006 | — |
| +1 | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | 3 |
| +2 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +3 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +4 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +5 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040876 | Iconnection, Version 3.2.0.0 Medical Image Processing SoftwareSummary page 1…(LLZ; Class II) ViTALConnect System- formally The iConnection System Identification of (K040876) Predicate Devices Vital Images, Inc. Device Description The ViTALConnect system is a medical diagno… | 2004 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071362 | Vital Connect 4.1 | 2007 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 21, 2013 | Class II | Z-0169-2014 | Software design | Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2… |
| Feb 5, 2013 | Class II | Z-1002-2013 | Software design | Vital Images has found a potential error in measurement generated through the software which affects all versions of Vitrea Enterprise Suite, Vitrea, VitreaAdvanced, VitreaCore (VitalConnect) and Vitrea fX prior to version 6.3.3, except… |
| Aug 23, 2010 | Not classified | Z-1021-2011 | Software design | There is a potential alignment error of fused PET/CT images in the Vitrea Core component of Vitrea Enterprise Suite 1.2 and 1.3. The error occurs during panning of the fused PET/CT images. Because the PET data has a larger voxel size than… |
| Nov 8, 2007 | Not classified | Z-0520-2008 | Process control | Standard Uptake Values (SUV) display/update problems; in the way Standard Uptake Values (SUV) are displayed in 3D/MPR views. The problem arises when a user draws a selected region of interest in order to calculate the SUV statistics of… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K071362 (Vital Images, Inc., 2007) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K040876.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a vanety of imaging devices including: CT, MR, CR/DRIDX, SC, US, NM, PET, -XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses: Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis…
Read the full statement (216 words)
ViTALConnect, Version 4.0 is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a vanety of imaging devices including: CT, MR, CR/DRIDX, SC, US, NM, PET, -XA, and RF, etc. In addition, the ViTALConnect system has the following specific intended uses:
Advanced Vessel Analysis is an option within the ViTALConnect system intended to aid clinicians in the study and analysis of selected vessels, the inspection of circulatory anatomy, the quantification of stenosis, distance measurements and cross-sectional diameters, volume measurements, and assist in the planning and monitoring of vascular therapies. The feature operates with CT and MRI data.
Pet Visualization is an option within the ViTALConnect system that provides for the overlay, inspection, and measurement of two different image modalities (primarily directed at PET/CT). The option also includes the ability to measure Standard Uptake Values on PET datasets.
The overlay operation enables clinicians to obtain a better understanding of the joint information that would otherwise have to be compared separately. It is important to note that the clinician retains the ultimate responsibility for making pertinent diagnosis based on their standard procedures, including visual comparison of separate images.
Collaboration Mode is a capability within the ViTALConnect system that allows multiple users to collaboratively interact with ViTALConnect system features and tools.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062154: Vital Connect 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062154
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026