Clarius Prostate AI
FDA 510(k) K243853 · Clarius Mobile Health Corp.
510(k) numberK243853
Submission
- Device name
- Clarius Prostate AI
- Applicant
- Clarius Mobile Health Corp.
Vancouver, CA - Received
- December 16, 2024
- Decision date
- April 16, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QIH – Automated Radiological Image Processing Software
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.2050
- Specialty
- Radiology
To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.
Other 510(k)s with product code QIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261795 | Quicktome Software SuiteQIH · Traditional | Omniscient Neurotechnology Pty, Ltd. | 09/10/2026SE |
| K260879 | 4DMQIH · Traditional | Invia, LLC | 09/10/2026SE |
| K251417 | ReVISION 2QIH · Traditional | Argus Cognitive, Inc. | 09/09/2026SE |
| K260525 | NextMR SpineQIH · Traditional | MRI2CT, Inc. | 09/04/2026SE |
| K260811 | Heartvue.ProtonQIH · Traditional | Heartvue.ai, Inc. | 08/26/2026SE |
| K261595 | Ceevra Reveal 4QIH · Traditional | Ceevra, Inc. | 08/25/2026SE |
| K262127 | DS Core CBCT AnatomyQIH · Traditional | Dentsply Sirona | 08/21/2026SE |
| K260584 | BoneMRIQIH · Traditional | Mriguidance B.V. | 08/21/2026SE |
| K261641 | Lower Limb AI (LLAI)QIH · Traditional | AI Planning Logic, Inc. | 08/18/2026SE |
| K253794 | Prostate CoreQIH · Traditional | Lucida Medical, Ltd. | 08/10/2026SE |
More from Lucida Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253593 | Clarius Ejection Fraction AIQIH · Traditional | 03/02/2026SE |
| K250226 | Clarius Median Nerve AIQIH · Traditional | 05/08/2025SE |
| K233955 | Clarius OB AIIYN · Traditional | 06/14/2024SE |
| K232257 | Clarius Bladder AIQIH · Traditional | 11/13/2023SE |
| K232704 | Clarius Ultrasound ScannerIYN · Special | 10/05/2023SE |
| K222406 | Clarius AIQIH · Traditional | 01/23/2023SE |
| K213436 | Clarius Ultrasound ScannerIYN · Special | 11/15/2021SE |
| K192107 | Clarius Ultrasound ScannerIYN · Abbreviated | 08/29/2019SE |
| K180799 | Clarius Ultrasound ScannerIYN · Traditional | 05/14/2018SE |
| K172385 | Clarius Ultrasound SystemIYN · Abbreviated | 09/14/2017SE |
Questions and answers
When was Clarius Prostate AI cleared by the FDA?
Clarius Prostate AI (K243853) received a 510(k) decision of Substantially Equivalent on April 16, 2025, 121 days after the submission was received.
What is the product code of K243853?
The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.