BoneMRI

FDA 510(k) K260584 · Mriguidance B.V.

Substantially Equivalent

510(k) numberK260584

Submission

Device name
BoneMRI
Applicant
Mriguidance B.V.
Utrecht, NL
Received
February 20, 2026
Decision date
August 21, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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.

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K261795Quicktome Software SuiteQIH · Traditional Omniscient Neurotechnology Pty, Ltd.09/10/2026SE
K2608794DMQIH · Traditional Invia, LLC09/10/2026SE
K251417ReVISION 2QIH · Traditional Argus Cognitive, Inc.09/09/2026SE
K260525NextMR SpineQIH · Traditional MRI2CT, Inc.09/04/2026SE
K260811Heartvue.ProtonQIH · Traditional Heartvue.ai, Inc.08/26/2026SE
K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE
K252571mdprostateQIH · Traditional Mediaire GmbH08/07/2026SE

More from Mediaire GmbH

510(k)DeviceDecision
K233030BoneMRIQIH · Traditional 03/01/2024SE
K230197BoneMRI v1.6QIH · Special 02/22/2023SE
K202404BoneMRIQIH · Traditional 12/22/2021SE

Questions and answers

When was BoneMRI cleared by the FDA?

BoneMRI (K260584) received a 510(k) decision of Substantially Equivalent on August 21, 2026, 182 days after the submission was received.

What is the product code of K260584?

The FDA product code is QIH – Automated Radiological Image Processing Software, a Class II (moderate risk) device regulated under 21 CFR 892.2050.