Clarius vs Pearl
A primary care practice scanning at the visit is Clarius's buyer, and a dental group reading bitewings is Pearl's. Clarius is a handheld ultrasound probe and Pearl reads dental X-rays, so the two answer separate purchases. The vendor says Clarius's T-Mode adds guidance on key anatomical structures, with a Primary Care variant.
Pearl sells to dental practices and groups. The vendor says Second Opinion marks up to 18 findings per image, but the openFDA decisions carry narrower indications. K210365 (March 2022) covers bitewing and periapical radiographs of permanent teeth in patients 12 and over, for suspected caries, restoration margin discrepancy, calculus and periapical radiolucency. K250525 (November 2025) covers panoramic radiographs for caries, periapical radiolucency and impacted third molars. K243893 covers caries in patients 4 and over with primary or mixed dentition. Pearl's FAQ names DEXIS, Carestream, Open Dental and Eaglesoft among its integrations, and its news page lists a Smile Brands rollout in June 2026.
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.
Pearl
by Pearl Inc. · founded 2019
FDA-cleared dental x-ray AI (Second Opinion) that marks caries, bone loss and restorations, for dentists and DSOs.
When to pick each one
Clarius
- Scanner for MSK, cardiac, bladder, OB and vascular work
- T-Mode anatomy guidance with a Primary Care variant, per vendor
Pearl
- Caries marking cleared for permanent teeth, patients 12 and over
- Panoramic clearance adds impacted third molars
- Connects to Open Dental, Eaglesoft, DEXIS and Carestream
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
Pearl
33of 100
| Dimension | Clarius | Pearl | 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 | 3 / 12 | 0 |
| Pricing transparency | 2.5 / 5 | 2.5 / 5 | 0 |
| Years in market | 0 / 6 | 4.2 / 6 | -4.2 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Pearl
| 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)
Pearl
FDA decisions
K250525 (opens in new tab)510(k)2025-11-14
Second Opinion Panoramic
K243234 (opens in new tab)510(k)2025-06-12
Second Opinion CS
K243989 (opens in new tab)510(k)2025-05-23
Second Opinion 3D
K243230 (opens in new tab)510(k)2025-05-09
Second Opinion BLE
K243893 (opens in new tab)510(k)2025-05-05
Second Opinion Pediatric
Show 3 more
K242600 (opens in new tab)510(k)2025-04-11
Second Opinion Periapical Radiolucency Contours
K242522 (opens in new tab)510(k)2025-01-16
Second Opinion CC
K210365 (opens in new tab)510(k)2022-03-04
Second Opinion
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | Pearl |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | 2019 |
| HQ | n/a | US |
Scroll horizontally to see both columns.
Common questions
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