Lunit vs Viz.ai
Lunit reads breast and chest images. Its 510(k)s cover INSIGHT MMG for mammography, INSIGHT DBT for tomosynthesis (version 1.2 decided in March 2026) and INSIGHT CXR Triage for chest X-ray. Volpara density and positioning tools now sit under the Lunit name. Lunit fits a breast imaging center running screening mammography first and a radiology group with a long chest X-ray queue second. An independent PLOS Digital Health comparison found a newer INSIGHT CXR version less accurate for TB reading until its threshold was recalibrated.
Viz.ai is a coordination platform for stroke and vascular teams. ContaCT received De Novo authorization for large vessel occlusion triage on CTA, and the vendor says Viz is embedded in 2,000 hospitals. Alerts reach clinicians through a mobile app and group messaging, which fits regional stroke programs that transfer patients between hospitals. Viz HCM also holds a De Novo authorization, next to 510(k)s for Viz ICH and Viz CTP.
Nobody weighs these two against each other. Breast and chest reading rooms buy one, and stroke and cardiac transfer teams buy the other.
Radiology · Reviewed November 2, 2026
When to pick each one
Lunit
- 510(k) cleared mammography and tomosynthesis AI
- INSIGHT CXR Triage is 510(k) cleared for chest X-ray
- Volpara density and positioning tools under the Lunit name
Viz.ai
- ContaCT received De Novo authorization for LVO on CTA
- Stroke, aneurysm, PE, aortic and cardiac modules
- Mobile alerts and messaging for transfer coordination
Score
Each row shows points earned of points available under the published rubric.
Lunit
66of 100
Viz.ai
89of 100
| Dimension | Lunit | Viz.ai | Difference |
|---|---|---|---|
| FDA clearance | 18 / 18 | 18 / 18 | 0 |
| HIPAA / SOC2 / BAA | 0 / 10 | 10 / 10 | -10 |
| 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 | 12.7 / 18.2 | 18.2 / 18.2 | -5.5 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 7.8 / 7.8 | 0 |
| Funding & adoption signal | 8.4 / 12 | 12 / 12 | -3.6 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 6 / 6 | 6 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Lunit
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Contact form only. |
Viz.ai
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Sold to health systems after a demo request. |
Evidence
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)
Viz.ai
FDA decisions
K250354 (opens in new tab)510(k)2025-06-10
Viz Subdural+
K232363 (opens in new tab)510(k)2024-02-05
Viz HDS, Viz Volume Plus, Viz ICH+
DEN230003 (opens in new tab)De Novo2023-08-03
Viz HCM
K223443 (opens in new tab)510(k)2023-03-17
Viz AAA
K223042 (opens in new tab)510(k)2022-10-21
Viz LVO (ContaCT)
Show 7 more
K221100 (opens in new tab)510(k)2022-08-29
Viz RV/LV
K220439 (opens in new tab)510(k)2022-07-25
Viz SDH
K213319 (opens in new tab)510(k)2022-02-18
Viz ANEURYSM
K210209 (opens in new tab)510(k)2021-03-23
Viz ICH
K193658 (opens in new tab)510(k)2020-03-18
Viz ICH
K180161 (opens in new tab)510(k)2018-04-20
Viz CTP
DEN170073 (opens in new tab)De Novo2018-02-13
ContaCT
Peer-reviewed
5 PubMed records name Viz.ai.
- Automated Emergent Large Vessel Occlusion Detection Using Viz.ai Software and Its Impact on Stroke Workflow Metrics and Patient Outcomes in Stroke Centers: A Systematic Review and Meta-analysis. (opens in new tab)
- Revolutionizing Intracranial Hemorrhage Diagnosis: A Retrospective Analytical Study of Viz.ai ICH for Enhanced Diagnostic Accuracy. (opens in new tab)
- Real-world evaluation of the accuracy of the Viz.AI automated intracranial hemorrhage volume calculation tool. (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Lunit | Viz.ai |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | 2013 | 2016 |
| HQ | KR | US |
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.


