510(k) · Cleared
Recalled · Class II · 2026CARESTREAM Vue Motion
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 Sep 21, 2015 as substantially equivalent to K132824 (Carestream Health, Inc., 2014) and 1 other predicate after an 82-day review. Its family tree reaches back 8 generations to 1984. 4 later devices descend from it. It has been recalled once.
- Decided
- Sep 21, 2015
- Review
- 82 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 8 generations to K842308 (1984). 29 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK842308 12SSL-SCMarquette Electronics, Inc. · 1984
- 7 generations backK980495 Muse Cardiovascular Information SystemMarquette Medical Systems, Inc. · 1998
- 6 generations backK992637 Muse Cardiovascular Information SystemGeneral Electric Medical Systems Information Techn · 1999 · Recalled
- 5 generations backK031970 Infinity MegacareSiemens Medical Solutions USA, Inc. · 2003
- 4 generations backK050858 Ascentia Heartstation Ecg Management SystemHeartlab, Inc. · 2005 · Recalled
- 3 generations backK061905 Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0Medcon, Ltd. · 2006
- 2 generations backK113515 Horizon Cardiology Ecg ManagementMckesson Israel, Ltd. · 2012 · Recalled
- 1 generation backK133534 Mckesson Cardiology Ecg MobileMckesson Israel, Ltd. · 2014
- This deviceK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 3 generations on · 0 of its ownK231385 Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · cites it directly3descendants
- K200822BraidBraid.Health · 2020 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 2 generations on0descendants
- K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K842308 | 12SSL-SC | Marquette Electronics, Inc. | 1984 | — |
| −7 | K980495 | Muse Cardiovascular Information System | Marquette Medical Systems, Inc. | 1998 | — |
| −6 | K992637 | Muse Cardiovascular Information System | General Electric Medical Systems Information Techn | 1999 | 1 |
| −5 | K031970 | Infinity Megacare | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −4 | K050858 | Ascentia Heartstation Ecg Management System | Heartlab, Inc. | 2005 | 1 |
| −3 | K061905 | Horizon Cardiology Ecg-Mckesson's Ecg Management System, Model 1.0 | Medcon, Ltd. | 2006 | — |
| −2 | K113515 | Horizon Cardiology Ecg Management | Mckesson Israel, Ltd. | 2012 | 2 |
| −1 | K133534 | Mckesson Cardiology Ecg Mobile | Mckesson Israel, Ltd. | 2014 | — |
| 0 (this device) | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | — |
| +1 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +2 | K200822 | Braid | Braid.Health | 2020 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +3 | K231385 | Rology Teleradiology Platform (v.1.22.1103) | Rology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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 |
|---|---|---|---|
| * | K132824 | Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationSummary page 4…s: CARESTREAM Vue Motion Manufactured by Carestream Health, Inc. 510(k) No. – K132824 (February 6, 2014) Primary Predicate McKesson Cardiolo… | 2014 |
| * | K133534 | Mckesson Cardiology Ecg MobileSummary page 4…McKesson CardiologyTM ECG Mobile Manufactured by McKesson Israel Ltd. 510(k) No. – K133534 (April 18, 2014) Secondary Predicate Device Description: CARESTREAM Vue Motion with ECG Fe… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170434 | Enterprise Imaging XERO Viewer 8.1 | 2017 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2026 | Class II | Z-1692-2026 | Software design | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 29 ancestors have a recall of any class.
- Of its descendants, K170434 (Agfa Healthcare N.V., 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K132824.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US. Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to…
Read the full statement (111 words)
The Vue Motion software program is used for patient management by clinicians in order to access and display patient data, medical reports, medical data, and medical images for diagnosis from different modalities including CR, DR, CT, MR, NM, ECG, and US.
Vue Motion provides wireless and portable access to medical images for remote reading or referral purposes from web browsers including usage with validated mobile devices. This device is not intended to replace full 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 FDA for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151774: CARESTREAM Vue Motion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151774
Report an extraction error
Are you the manufacturer?
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