Clarius vs Qure.ai
openFDA lists ten records under Qure.Ai Technologies, among them qER for head CT triage (June 2020), qXR-PTX-PE for pneumothorax and effusion triage (August 2023), qXR-LN for lung nodules on adult frontal chest radiographs (December 2023) and qCT Lung (September 2026). Qure's regulatory page lists seven FDA devices and states ISO 13485, ISO/IEC 27001 and MDSAP. Qure says it received a WHO endorsement in 2021 for chest X-ray TB screening. Its homepage shows sites across 107 countries and its regulatory page states registration in more than 85. The vendor says its software integrates with PACS and EMR systems without naming any.
Clarius Median Nerve AI was decided in May 2025 as K250226, and the vendor says it targets carpal tunnel. That fits a hand or orthopedic clinic scanning the median nerve in the exam room. Qure fits a radiology department or TB screening program, since its records cover head CT triage, chest X-ray detection and CT nodule quantification. A nerve question at the visit and a chest or head imaging read are separate needs, so these are separate buyers.
Radiology · Reviewed November 2, 2026
When to pick each one
Clarius
- FDA decision K250226 covers Median Nerve AI
- Vendor says Median Nerve AI targets carpal tunnel
Qure.ai
- Ten FDA 510(k) records across chest X-ray and CT
- ISO 13485, ISO 27001 and MDSAP on its regulatory page
- Qure says WHO endorsed its TB chest X-ray screening
Score
Each row shows points earned of points available under the published rubric.
Clarius
53of 100
Qure.ai
50of 100
| Dimension | Clarius | Qure.ai | 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 | 12.7 / 18.2 | 0 |
| 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 | 0 / 6 | 0 |
Scroll horizontally to see every column.
Pricing
Clarius
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price verified. |
Qure.ai
| Tier | Monthly | Annual | Notes |
|---|---|---|---|
| Enterprise | n/a | n/a | No public price. Grant funding is not stated on Qure pages. |
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)
Qure.ai
FDA decisions
K261517 (opens in new tab)510(k)2026-09-14
qCT Lung v1.0
K251934 (opens in new tab)510(k)2026-01-16
qXR-Detect
K251610 (opens in new tab)510(k)2025-09-08
qER-CTA v1.0
K240740 (opens in new tab)510(k)2024-08-16
qCT LN Quant
K231805 (opens in new tab)510(k)2023-12-22
qXR-LN
Show 5 more
K231149 (opens in new tab)510(k)2023-09-22
qXR-CTR
K230899 (opens in new tab)510(k)2023-08-22
qXR-PTX-PE
K212690 (opens in new tab)510(k)2021-12-21
qXR-BT
K211222 (opens in new tab)510(k)2021-07-30
qER-Quant
K200921 (opens in new tab)510(k)2020-06-17
qER
Peer-reviewed
4 PubMed records name Qure.ai.
- Radiograph accelerated detection and identification of cancer in the lung (RADICAL): a mixed methods study to assess the clinical effectiveness and acceptability of Qure.ai artificial intelligence software to prioritise chest X-ray (CXR) interpretation. (opens in new tab)
- Revolutionizing Healthcare: Qure.AI's Innovations in Medical Diagnosis and Treatment. (opens in new tab)
- A Case Series From a Multicentric Study: Can Artificial Intelligence (AI)-Enabled Chest X-Ray Assist in the Incidental Detection of Early-Stage Lung Cancers? (opens in new tab)
Compliance and integrations
Documented from each vendor’s own pages.
| Spec | Clarius | Qure.ai |
|---|---|---|
| Free tier | ||
| HIPAA | ||
| SOC 2 Type II | ||
| EHR integrations | Not specified | Not specified |
| Founded | n/a | n/a |
| HQ | n/a | IN |
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.