ScreenPoint Transpara vs TeraRecon
openFDA lists eight Transpara 510(k)s from K181704 on November 21, 2018 to K260898 on August 14, 2026, and Transpara Density (K232096) covers breast density. A group reading 2D and 3D mammograms, the setting of the MASAI screening trial, is the buyer, and the vendor calls the product vendor agnostic across FFDM and DBT systems. EU-Startups reported in April 2026 that ScreenPoint raised EUR 13.6M, EUR 11.9M of it equity from Insight Partners, Siemens Healthineers and others plus EUR 1.7M in grants.
TeraRecon sits in another department, with algorithms that run on CT and MR. DETECT runs imaging biomarkers during review, with modules for coronary plaque on cardiac CT, liver density on CT, and vertebral compression fractures and bone mineral density on chest or abdominal CT. TeraRecon Cardiac.Chambers.MR (K241312, November 5, 2024) segments cardiac chambers on adult MR, and Cardiovascular.Calcification.CT (K250288, October 23, 2025) outputs a calcium scoring mask for GE or Siemens CT only. A hospital cardiac imaging service is the buyer.
Radiology · Reviewed November 2, 2026

ScreenPoint Transpara
by ScreenPoint Medical
Transpara Breast AI: cancer detection support, density and risk tools for 2D and 3D mammograms.
TeraRecon
by ConcertAI · founded 1997
Advanced CT and MR visualization with cardiac, aorta and neuro AI, plus a vendor-agnostic platform to run third-party AI.
When to pick each one
ScreenPoint Transpara
- Detection and density on mammograms
- Latest 510(k) K260898, August 2026
- Works across FFDM and DBT systems, vendor says
TeraRecon
- DETECT plaque, hepatic and spine modules
- Cardiac chambers segmentation on MR, K241312
- Calcium scoring mask for GE or Siemens CT
Score
Each row shows points earned of points available under the published rubric.
ScreenPoint Transpara
56of 100
TeraRecon
42of 100
| Dimension | ScreenPoint Transpara | TeraRecon | 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 | 12.7 / 18.2 | 0 / 18.2 | +12.7 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 6 / 12 | 8.4 / 12 | -2.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
ScreenPoint Transpara
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Virtual demo and contact only. |
TeraRecon
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
ScreenPoint Transpara
FDA decisions
K260898 (opens in new tab)510(k)2026-08-14
Transpara (2.1.0)
K241831 (opens in new tab)510(k)2024-11-25
Transpara (2.1.0)
K232096 (opens in new tab)510(k)2023-12-11
Transpara Density 1.0.0
K221347 (opens in new tab)510(k)2022-08-03
Transpara 1.7.2
K210404 (opens in new tab)510(k)2021-06-02
Transpara 1.7.0
Show 3 more
K193229 (opens in new tab)510(k)2020-03-05
Transpara
K192287 (opens in new tab)510(k)2019-12-10
Transpara
K181704 (opens in new tab)510(k)2018-11-21
Transpara
Peer-reviewed
3 PubMed records name ScreenPoint Transpara.
- Interval cancer, sensitivity, and specificity comparing AI-supported mammography screening with standard double reading without AI in the MASAI study: a randomised, controlled, non-inferiority, single-blinded, population-based, screening-accuracy trial. (opens in new tab)
- Screening performance and characteristics of breast cancer detected in the Mammography Screening with Artificial Intelligence trial (MASAI): a randomised, controlled, parallel-group, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
- Artificial intelligence-supported screen reading versus standard double reading in the Mammography Screening with Artificial Intelligence trial (MASAI): a clinical safety analysis of a randomised, controlled, non-inferiority, single-blinded, screening accuracy study. (opens in new tab)
TeraRecon
FDA decisions
K250288 (opens in new tab)510(k)2025-10-23
TeraRecon Cardiovascular.Calcification.CT
K243158 (opens in new tab)510(k)2025-01-23
TeraRecon Aorta.CT (1.1.0)
K241312 (opens in new tab)510(k)2024-11-05
TeraRecon Cardiac.Chambers.MR (1.0.0)
K220349 (opens in new tab)510(k)2022-08-12
TeraRecon Neuro
K200750 (opens in new tab)510(k)2020-11-06
Neuro.AI Algorithm
Show 2 more
K191585 (opens in new tab)510(k)2019-07-12
iNtuition-Structural Heart Module
K180916 (opens in new tab)510(k)2018-09-24
iNtuition-T1 Mapping and T2/T2* Mapping
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | ScreenPoint Transpara | TeraRecon |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 1997 |
| HQ | NL | 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.
