510(k) · Cleared
ClearedImage 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 Sep 4, 2025 as substantially equivalent to K140271 (Carestream Health, Inc., 2014) after a 142-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Sep 4, 2025
- Review
- 142 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 11 ancestors in all, the oldest K941223 (1994). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- 3 generations backK083673 Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc. · 2008
- 2 generations backK100094 Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · Recalled
- 1 generation backK140271 Tablet Viewer Software for Image SuiteCarestream Health, Inc. · 2014
- This deviceK251168 Image SuiteCarestream Health, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| −3 | K083673 | Carestream Pacs, Model Carestream Pacs Vii | Carestream Health, Inc. | 2008 | — |
| −2 | K100094 | Carestream Image Suite | Carestream Heatlh, Inc. | 2010 | 2 |
| −1 | K140271 | Tablet Viewer Software for Image Suite | Carestream Health, Inc. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K140271 | Tablet Viewer Software for Image SuiteSummary page 6…ially available x-ray systems) • Smart Grid (cleared under K163157). This submission will also address cumulative changes made since the last 510(k) submission K140271. Over time minor changes have been made to the Image Suite product that have not impacted safety or effectiveness of the produc… | 2014 |
| † | K120062 | DRX-Revolution Mobile X-Ray System | 2012 |
| † | K133442 | Bone Suppression Software | 2014 |
| † | K163157 | SmartGrid | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Image Suite is a stand-alone radiographic imaging software designed to perform patient registration, review, report, archive, and print patient images. The software interacts with Carestream CR or DR to receive radiographic images for review, and has the ability to receive, archive, and review DICOM images from compatible third-party modalities (for example, US, MR, CT). The software can also update Carestream CR or DR device firmware and monitor device…
Read the full statement (127 words)
Image Suite is a stand-alone radiographic imaging software designed to perform patient registration, review, report, archive, and print patient images. The software interacts with Carestream CR or DR to receive radiographic images for review, and has the ability to receive, archive, and review DICOM images from compatible third-party modalities (for example, US, MR, CT). The software can also update Carestream CR or DR device firmware and monitor device calibration. The software serves as a web server to support web clients for image viewing. Image Suite is intended for use by radiologists and trained healthcare professionals. The software presents images to medical professionals in a convenient digital medium so they can make diagnostic and/or therapeutic decisions.
This excludes mammography applications and Tablet Viewer applications in the United States.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251168: 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/K251168
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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