Clarius vs TeraRecon
TeraRecon is advanced visualization plus an AI Framework that hosts third-party algorithms, with physician review before results are committed, per the vendor. Its pages describe CT and MR studies, and openFDA record K121916 (INTUITION, 2013) lists ultrasound among the accepted modalities. Among its cleared algorithms are Aorta.CT (January 2025), Cardiac.Chambers.MR (November 2024), Cardiovascular.Calcification.CT (October 2025, GE or Siemens CT only) and TeraRecon Neuro (August 2022). The vendor says it has more than 2,000 customers. SymphonyAI acquired it in 2020, and the vendor now brands itself ConcertAI's TeraRecon.
Clarius makes a wireless handheld scanner with the image on a phone or tablet. Its Ejection Fraction AI, which the vendor describes as left ventricular function in seconds, was decided in March 2026.
These answer different questions. EF at the visit is the cardiology office's reason to pick Clarius. One viewing and AI-hosting layer across CT and MR is the hospital radiology department's reason to pick TeraRecon.
Radiology · Reviewed November 2, 2026
Clarius
by Clarius Mobile Health
Wireless handheld ultrasound scanners with FDA-cleared onboard AI tools for bladder, prostate, OB and cardiac measurement.
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
Clarius
- Ejection Fraction AI decided March 2026 in openFDA
- Wireless handheld scanner, image on a phone or tablet
TeraRecon
- Vendor-agnostic platform for running third-party AI
- Cleared algorithms for aorta, cardiac MR, calcium scoring and neuro
- CT and MR visualization with a cardiac MR viewer
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
TeraRecon
42of 100
| Dimension | Clarius | 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 | 3 / 12 | 8.4 / 12 | -5.4 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 6 / 6 | -6 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
TeraRecon
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. |
Evidence
Clarius
FDA decisions
K253593 (opens in new tab)510(k)2026-03-02
Clarius Ejection Fraction AI
K250226 (opens in new tab)510(k)2025-05-08
Clarius Median Nerve AI
K243853 (opens in new tab)510(k)2025-04-16
Clarius Prostate AI
K233955 (opens in new tab)510(k)2024-06-14
Clarius OB AI
K232257 (opens in new tab)510(k)2023-11-13
Clarius Bladder AI
Show 1 more
K222406 (opens in new tab)510(k)2023-01-23
Clarius AI
Peer-reviewed
3 PubMed records name Clarius.
- Can handheld ultrasound probes reliably measure transabdominal prostate and bladder volumes? A prospective randomized point-of-care ultrasound study. (opens in new tab)
- Artificial Intelligence-Assisted Lung Ultrasound for Pneumothorax: Diagnostic Accuracy Compared with CT in Emergency and Critical Care. (opens in new tab)
- Validation of Handheld Ultrasound Devices for Point of Care Use in Rheumatology Study- Focus on Synovitis, Doppler Activity, Erosions, and Tendon Lesions. (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 | Clarius | TeraRecon |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 1997 |
| HQ | n/a | US |
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.