Circle Cardiovascular Imaging vs Lunit
Lunit's chest X-ray record is triage only (K211733), and its other openFDA records cover mammography and tomosynthesis: INSIGHT MMG (K211678, K260320) and INSIGHT DBT (K231470, K242652, K253796). Its buyers are breast imaging centers and chest X-ray services. Volpara density tools now sit under the Lunit name after an acquisition completed in 2024, which Radiology Business put at about US$193M, and Lunit has been listed on KOSDAQ since July 2022.
Circle's twelve openFDA records are cardiac MR and CT software, TruPlan, and two StrokeSENS records. Its cardiac CT calcium and plaque quantification and its cardiac MR strain and mapping serve a hospital cardiology department. The records put Lunit in the chest and breast rooms and Circle in cardiology. Among Lunit's six records there is no cardiac product, and among Circle's twelve there is none for the breast.
Radiology · Reviewed November 2, 2026
Circle Cardiovascular Imaging
by Circle Cardiovascular Imaging Inc. · founded 2007
cvi42 cardiac MR and CT software with FDA-cleared AI coronary plaque analysis and StrokeSENS acute stroke tools.
Lunit
by Lunit · founded 2013
AI for chest X-ray, mammography and breast tomosynthesis, Volpara breast-density tools, and pathology biomarker software (SCOPE).
When to pick each one
Circle Cardiovascular Imaging
- Cardiac CT calcium and plaque quantification
- Cardiac MR volumes, strain and mapping
Lunit
- Chest X-ray triage cleared as K211733
- Mammography and tomosynthesis with Volpara density tools
Score
Each row shows points earned of points available under the published rubric.
Circle Cardiovascular Imaging
42of 100
Lunit
66of 100
| Dimension | Circle Cardiovascular Imaging | Lunit | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 0 / 10 | 0 |
| EHR integrations (count) | 0 / 4.2 | 0 / 4.2 | 0 |
| Top-3 EHR coverage (Epic / Oracle / Athena) | 0 / 2.4 | 0 / 2.4 | 0 |
| Peer-reviewed papers | 0 / 18.2 | 12.7 / 18.2 | -12.7 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 8.4 / 12 | 8.4 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Circle Cardiovascular Imaging
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Lunit
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Contact form only. |
Evidence
Circle Cardiovascular Imaging
FDA decisions
K251027 (opens in new tab)510(k)2025-10-27
cvi42 Coronary Plaque Software Application
K250221 (opens in new tab)510(k)2025-07-01
StrokeSENS ASPECTS Software Application
K242781 (opens in new tab)510(k)2024-10-15
cvi42 Software Application
K241038 (opens in new tab)510(k)2024-06-07
Cardiac CT Function Software Application
K232661 (opens in new tab)510(k)2023-12-07
Myocardial Strain Software Application
Show 7 more
K222593 (opens in new tab)510(k)2023-01-18
TruPlan Computed Tomography Imaging Software
K213998 (opens in new tab)510(k)2022-07-28
cvi42 Auto Imaging Software Application
K212261 (opens in new tab)510(k)2021-10-14
StrokeSENS LVO
K202212 (opens in new tab)510(k)2021-02-19
TruPlan
K141480 (opens in new tab)510(k)2014-08-22
CVI42
K111373 (opens in new tab)510(k)2011-08-23
CT42 Cardiac CT Software
K082628 (opens in new tab)510(k)2008-11-20
CMR42 Cardiac MRI Imaging System
Lunit
FDA decisions
K260320 (opens in new tab)510(k)2026-04-23
Lunit INSIGHT MMG (v1.1.10)
K253796 (opens in new tab)510(k)2026-03-26
Lunit INSIGHT DBT (V1.2)
K242652 (opens in new tab)510(k)2024-10-04
Lunit INSIGHT DBT v1.1
K231470 (opens in new tab)510(k)2023-11-06
Lunit INSIGHT DBT
K211678 (opens in new tab)510(k)2021-11-17
Lunit INSIGHT MMG
Show 3 more
K211733 (opens in new tab)510(k)2021-11-10
Lunit INSIGHT CXR Triage
K211279 (opens in new tab)510(k)2021-07-27
Volpara Imaging Software
K182310 (opens in new tab)510(k)2018-09-21
Volpara Imaging Software
Peer-reviewed
3 PubMed records name Lunit.
- Comparison of different Lunit INSIGHT CXR software versions when reading chest radiographs for tuberculosis. (opens in new tab)
- Genomic and transcriptomic analyses of residual invasive triple-negative breast cancer after neoadjuvant chemotherapy in the prospective MIRINAE trial (a randomized phase II trial of adjuvant atezolizumab plus capecitabine compared to capecitabine; KCSG-BR18-21). (opens in new tab)
- Long-term prognostic implications of AI-detected versus AI-undetected breast cancers on mammography: a propensity score-matched analysis. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Circle Cardiovascular Imaging | Lunit |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2007 | 2013 |
| HQ | CA | KR |
Scroll horizontally to see both columns.
Common questions
Open the full radiology comparison
Acute-care triage, mammography screening, CCTA plaque analysis, mobile MRI. 30+ FDA-cleared platforms across stroke, oncology, cardiac. Enterprise sales only — we compared what's deployed where.