510(k) · Cleared
Recalled · Class II · 2013Vital Connect 4.1
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 May 30, 2007 as substantially equivalent to K062154 (Vital Images, Inc., 2006) and 1 other predicate after a 15-day review. Its family tree reaches back 9 generations to 1991. 11 later devices descend from it. It has been recalled 3 times.
- Decided
- May 30, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K913770 (1991). 37 ancestors in all, the oldest K896095 (1990). 11 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations between
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071362 Vital Connect 4.1Vital Images, Inc. · 2007
- Descendant · cites it directly · 8 of its ownK150738 VitreaViewVital Images, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK163232 Vitrea ViewVital Images, Inc. · 2017
- Descendant · 3 generations on · 6 of its ownK190764 SurgicalARMedivis, Inc. · 2019
- Descendant · 4 generations on · 2 of its ownK213215 VSI HoloMedicineApoqlar GmbH · 2022
- Descendant · 4 generations on · 1 of its ownK230249 IkshanaImmersivetouch · 2023
Show all 9 generations
- Root · 9 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 7 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 6 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 5 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 4 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 3 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 2 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 1 generation backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- This deviceK071362 Vital Connect 4.1Vital Images, Inc. · 2007
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K150738VitreaViewVital Images, Inc. · 2015 · cites it directly8descendants
- K163232Vitrea ViewVital Images, Inc. · 2017 · 2 generations on7descendants
- K190764SurgicalARMedivis, Inc. · 2019 · 3 generations on6descendants
- K213215VSI HoloMedicineApoqlar GmbH · 2022 · 4 generations on2descendants
- K230249IkshanaImmersivetouch · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −8 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −7 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −6 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −5 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −4 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −3 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −2 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −1 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| 0 (this device) | K071362 | Vital Connect 4.1 | Vital Images, Inc. | 2007 | — |
| +1 | K150738 | VitreaView | Vital Images, Inc. | 2015 | — |
| +2 | K163232 | Vitrea View | Vital Images, Inc. | 2017 | — |
| +3 | K190764 | SurgicalAR | Medivis, Inc. | 2019 | — |
| +4 | K213215 | VSI HoloMedicine | Apoqlar GmbH | 2022 | — |
| +4 | K230249 | Ikshana | Immersivetouch | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K062154 | Vital Connect 4.0Summary page 1…ation892.2050 Picture Archiving and Communications System Classification (LLZ; Class II) ViTALConnect Version 4.0 (K062 154) Identification of Vital Images, Inc. Predicate Devices Vitreao, Version 3.9 (K… | 2006 |
| * | K061624 | Vitrea, Version 3.9Summary page 1…ViTALConnect Version 4.0 (K062 154) Identification of Vital Images, Inc. Predicate Devices Vitreao, Version 3.9 (K061624) Vital Images, Inc. Device Description The ViTALConnect system is a medical diagnosti… | 2006 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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… |
| 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 16 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 8 of the 37 ancestors have a recall of any class.
- Of its descendants, K150738 (Vital Images, Inc., 2015) has gone furthest, with 8 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 4.1. is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. ViTALConnect is not meant for primary image interpretation in mammography. Inaddition, the ViTALConnect system has the following specific intended use: Vessel Probe is intended for viewing the…
Read the full statement (246 words)
ViTALConnect, Version 4.1. is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. ViTALConnect is not meant for primary image interpretation in mammography. Inaddition, the ViTALConnect system has the following specific intended use:
Vessel Probe is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians select any artery to view the following anatomical references: the highlighted vessel in 3D, two rotate-able curved MPR vessel views displayed at angles orthogonal to each other, and cross sections of the vessel. Cross sectional measurements can be obtained using standard Vital Images software measuring tools. Clinicians can manually measure the lumen width to obtain percentage stenosis calculations, based on the ratio of the smallest to the largest diameter. In addition, clinicians can manually measure vessel length along the centerline in standard curved MPR views and examine Hounsfield Units statistics.
CT Coronary Artery Analysis is intended for viewing the anatomy and pathology of a patient's coronary arteries. Clinicians can select any coronary artery to view the following anatomical references: the highlighted vessel in 3D, two rotatable curved MPR vessel views displayed at 90 degree angles to each other, and cross sections of the vessel. The clinician can semi-automatically determine contrasted lumen boundaries, stenosis measurements, and maximum and minimum lumen diameters. In addition, clinicians can edit lumen boundaries and examine Houndsfield unit statistics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071362: Vital Connect 4.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071362
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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