510(k) · Cleared
ClearedElucid FFR-IQ (B.1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elucid Bioimaging, Inc. · PJA Coronary Vascular Physiologic Simulation Software
Cleared on Sep 29, 2026 as substantially equivalent to DEN130045 (Heartflow, 2014) after a 106-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Sep 29, 2026
- Review
- 106 days
- Class
- Class II
- Product code
- PJA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN130045 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN130045 Heartflow FfrctHeartflow · 2014
- This deviceK262015 Elucid FFR-IQ (B.1)Elucid Bioimaging, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN130045 | Heartflow Ffrct | Heartflow | 2014 | — |
| 0 (this device) | K262015 | Elucid FFR-IQ (B.1) | Elucid Bioimaging, Inc. | 2026 | — |
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 K250902 HeartFlow Analysisscore 13.0 · 12 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 |
|---|---|---|---|
| * | DEN130045 | Heartflow FfrctSummary page 5…lar physiologic simulation software device Regulation Description Coronary vascular physiologic simulation software device 510(k) Number DEN130045 Regulation Number 870.1415 Device Class Class II Product Code PJA D… | 2014 |
| † | K241524 | Elucid PlaqueIQ | 2024 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN130045.
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. 2026, 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?
Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values computed from coronary CTA images using Al-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease. The FFR-IQ results are…
Read the full statement (107 words)
Elucid FFR-IQ is a coronary physiological simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable patients with suspected coronary artery disease. It provides FFR-CT (CT-derived FFR) values computed from coronary CTA images using Al-enabled algorithms. FFR-IQ is intended to support the functional evaluation of coronary artery disease.
The FFR-IQ results are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. FFR-IQ results are intended to be used by qualified clinicians in conjunction with the with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional ·udqment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K262015 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262015: Elucid FFR-IQ (B.1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262015
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026