510(k) · Cleared
ClearedHeartFlow Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
HeartFlow, Inc. · PJA Coronary Vascular Physiologic Simulation Software
Cleared on Jul 18, 2025 as substantially equivalent to K213857 (HeartFlow, Inc., 2022) and 1 other predicate after a 114-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Jul 18, 2025
- Review
- 114 days
- Class
- Class II
- Product code
- PJA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 75 ancestors in all, the oldest K871859 (1987). No later device cites it as a predicate yet.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- 1 generation backK213857 HeartFlow AnalysisHeartFlow, Inc. · 2022
- This deviceK250902 HeartFlow AnalysisHeartFlow, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 10 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 9 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 8 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 7 generations backK040305 VITREA2 Version 3.5Vital Images, Inc. · 2004
- 6 generations backK043333 VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc. · 2004 · Recalled
- 5 generations backK052632 VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc. · 2005 · Recalled
- 4 generations backK061624 Vitrea, Version 3.9Vital Images, Inc. · 2006 · Recalled
- 3 generations backK071331 Vitrea Version 4.0Vital Images, Inc. · 2007 · Recalled
- 2 generations backK122429 Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc. · 2012
- 1 generation backK213857 HeartFlow AnalysisHeartFlow, Inc. · 2022
- This deviceK250902 HeartFlow AnalysisHeartFlow, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −10 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −9 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −8 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −7 | K040305 | VITREA2 Version 3.5 | Vital Images, Inc. | 2004 | — |
| −6 | K043333 | VITREA2, Version 3.7 Medical Image Processing System | Vital Images, Inc. | 2004 | 1 |
| −5 | K052632 | VITREA2 Version 3.8 Medical Image Processing Software | Vital Images, Inc. | 2005 | 2 |
| −4 | K061624 | Vitrea, Version 3.9 | Vital Images, Inc. | 2006 | 1 |
| −3 | K071331 | Vitrea Version 4.0 | Vital Images, Inc. | 2007 | 1 |
| −2 | K122429 | Vessel Analysis and Autoplaque for Ors Visual | Object Research Systems (Ors), Inc. | 2012 | — |
| −1 | K213857 | HeartFlow Analysis | HeartFlow, Inc. | 2022 | — |
| 0 (this device) | K250902 | HeartFlow Analysis | HeartFlow, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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 PJA? 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 PJA device
- #1 K262015 Elucid FFR-IQ (B.1)score 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K213857 | HeartFlow AnalysisSummary page 6…software device 3. Predicates This submission leverages Heartflow Analysis (K213857) as the primary predicate and Autoplaque (K122429) as an additional predicate, for validation of the plaque feature. 4. Devic… | 2022 |
| * | K122429 | Vessel Analysis and Autoplaque for Ors VisualSummary page 6…software device 3. Predicates This submission leverages Heartflow Analysis (K213857) as the primary predicate and Autoplaque (K122429) as an additional predicate, for validation of the plaque feature. 4. Device Description The Heartflow Analysis is an AI-base… | 2012 |
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 34 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 15 of the 75 ancestors have a recall of any class.
How does its category compare?
All PJA devicesPJA Coronary Vascular Physiologic Simulation Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PJA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PJA
Too few PJA 510(k)s in any year since 2007 to give a median.
Recalls per year · PJA
No recall names PJA since 2007.
Adverse event reports per year · PJA
16in 2025
MAUDE reports naming product code PJA, 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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 1 | — | 0 | 65 |
| 2020 | 0 | — | 0 | 9 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 16 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Heartflow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for adult patients (ages 22 years and older) with suspected coronary artery disease. It provides anatomic data, plaque localization and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow…
Read the full statement (144 words)
The Heartflow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for adult patients (ages 22 years and older) with suspected coronary artery disease. It provides anatomic data, plaque localization and characterization, as well as the calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. The Heartflow Analysis is intended to support the risk assessment and functional evaluation of coronary artery disease.
The Heartflow Analysis is provided to support qualified clinicians to aid in the evaluation and risk assessment of coronary artery disease. The Heartflow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250902 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250902: HeartFlow Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250902
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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