510(k) · Cleared
ClearedTablet Viewer Software for Image Suite
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 Apr 1, 2014 as substantially equivalent to K100094 (Carestream Heatlh, Inc., 2010) after a 57-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Apr 1, 2014
- Review
- 57 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954678 (1996). 10 ancestors in all, the oldest K941223 (1994). 1 later device descends from it, 1 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 backK100094 Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · Recalled
- This deviceK140271 Tablet Viewer Software for Image SuiteCarestream Health, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK251168 Image SuiteCarestream Health, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251168Image SuiteCarestream Health, Inc. · 2025 · cites it directly0descendants
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 | K100094 | Carestream Image Suite | Carestream Heatlh, Inc. | 2010 | 2 |
| 0 (this device) | K140271 | Tablet Viewer Software for Image Suite | Carestream Health, Inc. | 2014 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K100094 | Carestream Image SuiteSummary page 1…icate Device: Image Suite Manufactured by Carestreamn Health, Inc. 510(k) Number - K100094 (March 11, 2010) 64 Carestr… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251168 | Image Suite | 2025 | 0 |
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 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K251168 (Carestream Health, Inc., 2025) has gone furthest, with 0 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. 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?
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. Tablet Viewer Software for Image Suite 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, CT, MR, and US. Tablet Viewer Software for Image Suite…
Read the full statement (128 words)
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.
Tablet Viewer Software for Image Suite 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, CT, MR, and US.
Tablet Viewer Software for Image Suite 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 the full Mini-PACS and should be used only when there is no access to the full Mini-PACS Web Viewer.
This excludes mammography applications in the United States.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140271: Tablet Viewer Software for Image Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140271
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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