510(k) · Cleared
ClearedChange Healthcare Stratus Imaging PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Change Healthcare Canada Company · LLZ System, Image Processing, Radiological
Cleared on Nov 12, 2024 as substantially equivalent to K203249 (Nucleushealth, LLC, 2020) after a 130-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Nov 12, 2024
- Review
- 130 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945188 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 6 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 5 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 4 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 3 generations backK072205 Visage Pacs/CS, Release Version 5.0Mercury Computer Systems, Inc. · 2007
- 2 generations backK082269 Visage Pacs, Version 6.0/CS 3.1Visage Imaging, Inc. · 2008
- 1 generation backK203249 Nucleus.ioNucleushealth, LLC · 2020 · Recalled
- This deviceK241981 Change Healthcare Stratus Imaging PACSChange Healthcare Canada Company · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −6 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −5 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −4 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −3 | K072205 | Visage Pacs/CS, Release Version 5.0 | Mercury Computer Systems, Inc. | 2007 | — |
| −2 | K082269 | Visage Pacs, Version 6.0/CS 3.1 | Visage Imaging, Inc. | 2008 | — |
| −1 | K203249 | Nucleus.io | Nucleushealth, LLC | 2020 | 1 |
| 0 (this device) | K241981 | Change Healthcare Stratus Imaging PACS | Change Healthcare Canada Company | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 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 21.6 · 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 |
|---|---|---|---|
| * | K203249 | Nucleus.ioSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K203249 Change Healthcare Stratus Imaging PACS; Nucleus.io 7LLZ I Device Desc… | 2020 |
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 7 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K203249.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians. The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image post-processing functions such…
Read the full statement (161 words)
Change Healthcare Stratus Imaging PACS is a software-based medical image management and processing system intended to process and display medical images for the purposes of diagnostic viewing and interpretation by qualified and trained healthcare professionals, including, but not restricted to, radiologists and non-radiology physicians.
The Diagnostic Viewer of Change Healthcare Stratus Imaging PACS provides medical image post-processing functions such as image manipulation and enhancement that are intended for use in the clinical image review and analysis of medical images acquired through DICOM-compliant imaging devices or IT interfaces.
Change Healthcare Stratus Imaging PACS can be used as a full-featured medical image management and processing system or as an independent viewer in clinical settings.
Only uncompressed or non-lossy compressed DICOM images can be used for primary image diagnosis and interpretation for mammography using monitors intended for mammography display and cleared by the regulatory authority in your region or jurisdiction.
Change Healthcare Stratus Imaging PACS is not intended for diagnostic use on mobile devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K241981: Change Healthcare Stratus Imaging PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K241981
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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