510(k) · Cleared
ClearedCarestream Pacs, Model Carestream Pacs Vii
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 Dec 30, 2008 as substantially equivalent to K020546 (Mirada Solutions, Ltd., 2002) after a 19-day review. Its family tree reaches back 4 generations to 1996. 12 later devices descend from it.
- Decided
- Dec 30, 2008
- Review
- 19 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954678 (1996). 7 ancestors in all, the oldest K941223 (1994). 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 3 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 2 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 1 generation backK020546 Fusion 7DMirada Solutions, Ltd. · 2002
- This deviceK083673 Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc. · 2008
- Descendant · cites it directly · 8 of its ownK110919 Carestream PacsCarestream Health, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK132824 Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK151774 CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · cites it directly · 2 of its ownK100094 Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K110919Carestream PacsCarestream Health, Inc. · 2011 · cites it directly8descendants
- K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc. · 2014 · 2 generations on6descendants
- K151774CARESTREAM Vue MotionCarestream Health, Inc. · 2015 · 3 generations on4descendants
- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · 4 generations on3descendants
- K100094Carestream Image SuiteCarestream Heatlh, Inc. · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −3 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −2 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −1 | K020546 | Fusion 7D | Mirada Solutions, Ltd. | 2002 | — |
| 0 (this device) | K083673 | Carestream Pacs, Model Carestream Pacs Vii | Carestream Health, Inc. | 2008 | — |
| +1 | K110919 | Carestream Pacs | Carestream Health, Inc. | 2011 | 50 |
| +2 | K132824 | Carestream Vue Pacs Version 11.4 Carestream Vue Motion Application | Carestream Health, Inc. | 2014 | — |
| +3 | K151774 | CARESTREAM Vue Motion | Carestream Health, Inc. | 2015 | 1 |
| +4 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +1 | K100094 | Carestream Image Suite | Carestream Heatlh, Inc. | 2010 | 2 |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K020546 | Fusion 7DSummary page 1…Ltd, Fusion 7D Manufactured by Siemens Medical Solutions, Inc 5 10(k) No. - K020546 (April 26, 2002) TITLE: 5 10(k) Summary Carestream PACS 11 PART #: 8G7624 VERSION # 1.0… | 2002 |
What descends from it? (12)
See all 122 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)
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 12 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K110919 (Carestream Health, Inc., 2011) has gone furthest, with 8 descendants of its own.
- 8 other devices also cite its predicate K020546.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 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 (3D) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083673 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083673: Carestream Pacs, Model Carestream Pacs Vii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083673
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