510(k) · Cleared
Recalled · Class II · 2024Carestream Pacs
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 Oct 20, 2011 as substantially equivalent to K083673 (Carestream Health, Inc., 2008) after a 202-day review. Its family tree reaches back 5 generations to 1996. 8 later devices descend from it. It has been recalled 50 times.
- Decided
- Oct 20, 2011
- Review
- 202 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 50
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954678 (1996). 8 ancestors in all, the oldest K941223 (1994). 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 4 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 3 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 2 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 1 generation backK083673 Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc. · 2008
- This deviceK110919 Carestream PacsCarestream Health, Inc. · 2011
- Descendant · cites it directly · 6 of its ownK132824 Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 4 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
2014high 1 (2014) · low 0 (2016)2026
Most influential descendants
Showing 5 of 8 · See all- K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc. · 2014 · cites it directly6descendants
- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 2 generations on4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 3 generations on3descendants
- K200822BraidBraid.Health · 2020 · 4 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −4 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −3 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −2 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −1 | K083673 | Carestream Pacs, Model Carestream Pacs Vii | Carestream Health, Inc. | 2008 | — |
| 0 (this device) | K110919 | Carestream Pacs | Carestream Health, Inc. | 2011 | — |
| +1 | K132824 | Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application | Carestream Health, Inc. | 2014 | — |
| +2 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +3 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +4 | K200822 | Braid | Braid.Health | 2020 | — |
| +4 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K083673 | Carestream Pacs, Model Carestream Pacs ViiSummary page 1…vice: Carestreamn PACS Manufactured by Carestream Health, Inc. 5 10(k) No. - K083673 (December 30, 2008) TITLE: 510(k) Summary PART t4:6J5396 VERSION # 210 Unrestricted in… | 2008 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 10, 2024 | Class II | Z-0497-2025 | Software design | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to… |
| Sep 16, 2013 | Class II | Z-0248-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0229-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0255-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0250-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0228-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0243-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0214-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0216-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0218-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0222-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0240-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0224-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0259-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0211-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0236-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0238-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0251-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0235-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0257-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0258-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0220-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0237-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0217-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0223-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0225-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0239-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0221-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0242-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0246-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0252-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0226-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0215-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0232-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0230-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0233-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0241-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0212-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0249-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0244-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0253-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0219-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0256-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0254-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0231-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0213-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0227-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0245-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0260-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
| Sep 16, 2013 | Class II | Z-0234-2014 | Software design | Carestream Health, Inc. has issued a recall when using the CARESTREAM Client Workstation where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application due to a… |
The 5 latest of 50 recalls; the web page lists all.
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 2.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K132824 (Carestream Health, Inc., 2014) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K083673.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2007high 106 (2011) · low 51 (2010)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
2007high 173 (2025) · low 36 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
2007high 64 (2013) · low 2 (2019)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
2007high 15,631 (2014) · low 26 (2023)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 PACS is an image management system whose intended use is to provide completely scaleable 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 (31D) images. It is a single system…
Read the full statement (193 words)
The CARESTREAM PACS is an image management system whose intended use is
to provide completely scaleable 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 (31D) images. It is a single system that integrates the
review, dictation and reporting tools that creates a productive work environment for
the radiologists and physicians.
The CARESTREAM PACS Lightweight Viewer software program is used for patient
management by the referral community in order to access and display patient data,
medical reports, and medical images from different modalities including CR, DR, CT,
MR, NM and US after the primary reading has been completed on dedicated
diagnostic workstations,
The CARESTREAM PACS Lightweight Viewer provides wireless and portable
access to medical images for referral purposes. It is not intended to be used as, or
to replace, a full diagnostic workstation or system and should be used only when
there is no access to a workstation. This device is not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110919 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110919: Carestream Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110919
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