Clarius vs DeepHealth
Bladder and prostate volumes at the bedside are one job, and screening mammograms read in a radiology department are another, so these vendors sell to different buyers. Clarius's Bladder AI (K232257, decided November 13, 2023) and Prostate AI (K243853, decided April 16, 2025) run on its wireless probe, which the company has sold since December 2016 and takes orders for by store checkout or quote request. A urology or primary care clinic is the Clarius buyer.
DeepHealth sells Saige-Dx mammography detection (K253825, decided June 15, 2026) to breast imaging groups and hospital radiology departments, and its homepage shows no price. RadNet announced the DeepHealth acquisition on March 11, 2020. openFDA lists 12 records under Clarius Mobile Health Corp., six of them AI-named, and 10 under DeepHealth, Inc.
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.
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.
When to pick each one
Clarius
- Bladder and prostate volume measurement on a bedside probe
- Vendor says wireless probe sold since December 2016
DeepHealth
- Saige-Dx mammography detection, latest clearance June 2026
- Diagnostic Suite and Operations Suite for enterprise imaging
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
DeepHealth
48of 100
| Dimension | Clarius | DeepHealth | 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 | 7.3 / 18.2 | +5.5 |
| RCT / meta-analysis / systematic review | 7.8 / 7.8 | 0 / 7.8 | +7.8 |
| Funding & adoption signal | 3 / 12 | 12 / 12 | -9 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
DeepHealth
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. The homepage shows none. |
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)
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.
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | DeepHealth |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | US |
Scroll horizontally to see both columns.
Common questions
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