510(k) · Cleared
Recalled · Class II · 2016Carestream Image Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Heatlh, Inc. · LLZ System, Image Processing, Radiological
Cleared on Mar 11, 2010 as substantially equivalent to K083673 (Carestream Health, Inc., 2008) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1996. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 11, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K954678 (1996). 9 ancestors in all, the oldest K941223 (1994). 2 later devices descend from it, 1 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 deviceK100094 Carestream Image SuiteCarestream Heatlh, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK140271 Tablet Viewer Software for Image SuiteCarestream Health, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK251168 Image SuiteCarestream Health, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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) | K100094 | Carestream Image Suite | Carestream Heatlh, Inc. | 2010 | — |
| +1 | K140271 | Tablet Viewer Software for Image Suite | Carestream Health, Inc. | 2014 | — |
| +2 | K251168 | Image Suite | Carestream Health, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K083673 | Carestream Pacs, Model Carestream Pacs ViiSummary page 1…ulation Number 21 CFR 892.2050, Picture Archiving and Communications System Predicate Device K083673 - Device Name: CARESTREAM PACS Vii1 K060137… | 2008 |
| * | K060137 | Kodak Eclipse Image Processing SoftwareSummary page 1…tem Predicate Device K083673 - Device Name: CARESTREAM PACS Vii1 K060137 - Device Name: Kodak Eclipse Image Processing Software Device Description CAREST… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140271 | Tablet Viewer Software for Image Suite | 2014 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 15, 2016 | Class II | Z-1594-2016 | Software design | Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". |
| Apr 15, 2016 | Class II | Z-1593-2016 | Software design | Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K140271 (Carestream Health, Inc., 2014) has gone furthest, with 1 descendant 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. 2010, 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?
CARESTREAM Image Suite is an image management system whose intended use is to receive, process, review, display, print and archive images and data from all imaging modalities. This excludes mammography applications in the United States.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100094: Carestream Image Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100094
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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