510(k) · Cleared
ClearedCarestream Vue Pacs Version 11.4 Carestream Vue Motion Application
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · LLZ System, Image Processing, Radiological
Cleared on Feb 6, 2014 as substantially equivalent to K110919 (Carestream Health, Inc., 2011) after a 150-day review. Its family tree reaches back 6 generations to 1996. 6 later devices descend from it.
- Decided
- Feb 6, 2014
- Review
- 150 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 9 ancestors in all, the oldest K941223 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 4 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 3 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 2 generations backK083673 Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc. · 2008
- 1 generation backK110919 Carestream PacsCarestream Health, Inc. · 2011 · Recalled
- This deviceK132824 Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · 3 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 3 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 4 generations on · 0 of its ownK231385 Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · cites it directly4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 2 generations on3descendants
- K200822BraidBraid.Health · 2020 · 3 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 3 generations on0descendants
- K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −5 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −4 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −3 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −2 | K083673 | Carestream Pacs, Model Carestream Pacs Vii | Carestream Health, Inc. | 2008 | — |
| −1 | K110919 | Carestream Pacs | Carestream Health, Inc. | 2011 | 50 |
| 0 (this device) | K132824 | Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application | Carestream Health, Inc. | 2014 | — |
| +1 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +2 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +3 | K200822 | Braid | Braid.Health | 2020 | — |
| +3 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +4 | K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|
| * | K110919 | Carestream Pacs | 2011 |
What descends from it? (6)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K151774 (Carestream Health, Inc., 2015) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K110919.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems. The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system…
Read the full statement (196 words)
The CARESTREAM Vue PACS is an image management system whose intended use is to provide completely scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and data from all hospital modalities and information systems.
The system contains interactive tools in order to ease the process of analyzing and comparing three dimensional (3D) images. It is a single system that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians.
The Wue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, and medical images for diagnosis from different modalities including CR, DR, C, MR, NM and US.
Vue Motion provides wireless and portable access to mnedical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace ful workstations and should be used only when there is no access to a workstation. For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by the FDA for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132824 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132824: Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132824
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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