510(k) · Cleared
ClearedChange Healthcare Anatomical AI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Change Healthcare Canada Company · QIH Automated Radiological Image Processing Software
Cleared on Jul 20, 2021 as substantially equivalent to K061214 (Terarecon,Inc., 2006) after a 132-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 20, 2021
- Review
- 132 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 5 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 4 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 3 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 2 generations backK041807 Lung Car 1.1Medicsight · 2004
- 1 generation backK061214 Aquariusaps ServerTerarecon,Inc. · 2006
- This deviceK210719 Change Healthcare Anatomical AIChange Healthcare Canada Company · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −5 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −4 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −3 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −2 | K041807 | Lung Car 1.1 | Medicsight | 2004 | — |
| −1 | K061214 | Aquariusaps Server | Terarecon,Inc. | 2006 | — |
| 0 (this device) | K210719 | Change Healthcare Anatomical AI | Change Healthcare Canada Company | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 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 |
|---|---|---|---|
| * | K061214 | Aquariusaps ServerSummary page 5…image management and processing system 1.4. Predicate Device Identification Proprietary Name(s): AquariusAPS Server 510(k) Number: K061214 Applicant: TeraRecon, Inc. No reference devices were used in this submission. Cha… | 2006 |
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 30 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 30 ancestors have a recall of any class.
- 7 other devices also cite its predicate K061214.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
Change Healthcare Anatomical AI is intended to analyze pixel data from CT or MR images to create comprehensive anatomic descriptors for export to integrated healthcare systems.
This supplements traditional methods used for the selection, presentation or analysis of image based medical data. The application is intended to enable physicians, or other healthcare providers as well as integrated healthcare systems to rapidly identify images, series, and/ or studies of interest.
Change Healthcare Anatomical AI is not indicated for patients under the age of 18 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210719 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210719: Change Healthcare Anatomical AI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210719
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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