DeepHealth vs Lunit
Lunit's mammography record runs through April 2026: INSIGHT DBT v1.2 in March and INSIGHT MMG v1.1.10 in April, plus Volpara density and positioning software it bought in 2024 for about US$193 million. Its chest X-ray FDA record is INSIGHT CXR Triage, and an independent PLOS Digital Health comparison found a newer INSIGHT CXR version less accurate on TB reads until its threshold was recalibrated. Lunit also holds MDR CE marks for mammography and chest X-ray. DeepHealth answers with Saige-Dx (June 2026) and Saige-Density plus breast arterial calcification software cleared in May 2026. Lunit gives ground to DeepHealth for a US group that wants calcification reads from its screening mammograms, since none of Lunit's six openFDA records is a calcification product and DeepHealth holds K254131. European and Asia-Pacific screening services lean to Lunit for the CE marks, and US breast imaging groups adding calcification reads lean to DeepHealth.
Radiology · Reviewed November 2, 2026
DeepHealth
by RadNet / DeepHealth, Inc.
Imaging AI from RadNet's DeepHealth: mammography (Saige-Dx, Saige-Density), breast arterial calcification, prostate, lung, bone and chest X-ray.
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
DeepHealth
- Breast arterial calcification clearance K254131, May 2026
- Saige-Dx and Saige-Density mammography pair
- Gleamer chest X-ray product added in 2026
Lunit
- INSIGHT DBT v1.2 cleared March 2026
- INSIGHT MMG v1.1.10 cleared April 2026
- MDR CE marks for chest X-ray and mammography
Score
Each row shows points earned of points available under the published rubric.
DeepHealth
48of 100
Lunit
66of 100
| Dimension | DeepHealth | 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 | 7.3 / 18.2 | 12.7 / 18.2 | -5.5 |
| RCT / meta-analysis / systematic review | 0 / 7.8 | 7.8 / 7.8 | -7.8 |
| Funding & adoption signal | 12 / 12 | 8.4 / 12 | +3.6 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
DeepHealth
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage shows none. |
Lunit
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Contact form only. |
Evidence
DeepHealth
FDA decisions
K252486 (opens in new tab)510(k)2026-09-09
ChestView US 1.1 (Gleamer)
K253825 (opens in new tab)510(k)2026-06-15
Saige-Dx
K254131 (opens in new tab)510(k)2026-05-21
Breast arterial calcification (BAC) software
K251873 (opens in new tab)510(k)2025-08-11
Saige-Dx
K243703 (opens in new tab)510(k)2025-06-05
TechLive
Show 13 more
K241620 (opens in new tab)510(k)2025-02-27
ChestView US (Gleamer)
K241593 (opens in new tab)510(k)2025-02-05
BoneMetrics (Gleamer)
K243688 (opens in new tab)510(k)2024-12-19
Saige-Dx 3.1.0
K243705 (opens in new tab)510(k)2024-12-19
Saige-Density 2.5.0
K241747 (opens in new tab)510(k)2024-11-18
Saige-Dx
K240417 (opens in new tab)510(k)2024-11-08
ProFound Detection V4.0 (iCAD)
K222176 (opens in new tab)510(k)2023-03-02
BoneView (Gleamer)
K222275 (opens in new tab)510(k)2022-12-16
Saige-Density
K220105 (opens in new tab)510(k)2022-05-12
Saige-Dx
K212365 (opens in new tab)510(k)2022-03-01
BoneView (Gleamer)
K203517 (opens in new tab)510(k)2021-04-16
Saige-Q (triage)
K203822 (opens in new tab)510(k)2021-03-12
ProFound AI V3.0 (iCAD)
K191994 (opens in new tab)510(k)2019-10-04
ProFound AI V2.1 (iCAD)
Peer-reviewed
1 PubMed record names DeepHealth.
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 | DeepHealth | Lunit |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2013 |
| HQ | US | KR |
Scroll horizontally to see both columns.
Common questions
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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.