BoneMRI v1.6

FDA 510(k) K230197 · Mriguidance B.V.

Substantially Equivalent

510(k) numberK230197

Submission

Device name
BoneMRI v1.6
Applicant
Mriguidance B.V.
Utrecht, NL
Received
January 25, 2023
Decision date
February 22, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 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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K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K260584BoneMRIQIH · Traditional Mriguidance B.V.08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE

More from Lucida Medical, Ltd.

510(k)DeviceDecision
K260584BoneMRIQIH · Traditional 08/21/2026SE
K233030BoneMRIQIH · Traditional 03/01/2024SE
K202404BoneMRIQIH · Traditional 12/22/2021SE

Questions and answers

When was BoneMRI v1.6 cleared by the FDA?

BoneMRI v1.6 (K230197) received a 510(k) decision of Substantially Equivalent on February 22, 2023, 28 days after the submission was received.

What is the product code of K230197?

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