Clarius AI
K222406Clarius Mobile Health Corp. · cleared 2023-01-23 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Clarius AI is a radiological (ultrasound) image processing software application which implements artificial intelligence (AI), including non-adaptive machine learning algorithms, and is incorporated into the Clarius App software for use as part of the complete Clarius Ultrasound Scanner system product offering in musculoskeletal (MSK) ultrasound imaging applications.”
source quote (p.10)
“Image segmentation, anatomical identification, and measurement utilizing the machine learning-based algorithm Exception U-Net”
source quote (p.5)
“artificial intelligence (AI), including non-adaptive machine learning algorithms”
source quote (p.13)
“Clarius conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient.”
Validation studies (1)
Retrospective clinical
n=73 patients
endpoints: determine whether the Clarius AI (MSK model) software measurement output adequately aligned with expert clinicians' manual caliper placement; non-inferiority of automatic thickness measurement compared to mean manual measurements
standards: IEC 62304:2006 + A1:2015 - Medical device software - Software life cycle processes, ISO 14971:2019 Medical devices - Application of risk management to medical devices, NEMA PS 3.1 - 3.20 (2016) Digital Imaging and Communications in Medicine (DICOM) Set, IEC 62366-1:2015 + A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices, ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied, General Principles of Software Validation, Final Guidance for Industry and FDA Staff (issued January 11, 2002), Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005), Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (issued October 2, 2014)
Reported performance (2 observations)
source quote (p.14)
“The reported average Dice score was 96%”
source quote (p.14)
“the mean IoU was 94% for tendon segmentation.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K253593 (decision 2026-03-02) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ejection Fraction AI") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.
first seen 2026-07-08 · k_number:K253593
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250226 (decision 2025-05-08) from Clarius Mobile Health Corp. for a matching device line ("Clarius Median Nerve AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250226
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243853 (decision 2025-04-16) from Clarius Mobile Health Corp. for a matching device line ("Clarius Prostate AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243853
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233955 (decision 2024-06-14) from Clarius Mobile Health Corp. for a matching device line ("Clarius OB AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K233955
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232257 (decision 2023-11-13) from Clarius Mobile Health Corp. for a matching device line ("Clarius Bladder AI") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232257
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K232704 (decision 2023-10-05) from Clarius Mobile Health Corp. for a matching device line ("Clarius Ultrasound Scanner") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K232704
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).