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BoneMRI v1.6

by Mriguidance B.V.

510(k) K230197

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230197↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK230197 Date22 Feb 2023ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
QIH
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

BoneMRI v1.6 is a Class II medical imaging software device designed to generate radiation-free, CT-like tomographic images from MRI scans. It employs artificial intelligence, specifically a convolutional neural network, to convert 3D gradient echo MRI data into quantitative radiodensity contrast images measured in Hounsfield Units (HU). The device is intended for spine and pelvic anatomy imaging in both adults and adolescents, providing sub-millimeter precision.

BoneMRI v1.6 is supplied as standalone software, requiring integration with MRI systems to process 3D gradient echo scans. It is classified under the Medical Device Regulation (MDR) and holds FDA 510(k) clearance (K230197) as substantially equivalent to a predicate device, filed under the Radiology advisory committee. The device is not sterile, single-use, or reusable, and no MRI safety classification or sterility information is specified in the regulatory data.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of MRI scans does BoneMRI v1.6 require to generate its images, and how does it differ from standard MRI outputs?

    BoneMRI v1.6 specifically processes 3D gradient echo MRI scans to create radiation-free, CT-like images. Unlike conventional MRI, which provides detailed soft-tissue contrast, BoneMRI uses artificial intelligence (a convolutional neural network) to convert these scans into quantitative radiodensity images measured in Hounsfield Units (HU). This enables clearer visualization of bone structures like the spine and pelvis with sub-millimeter precision, mimicking the density resolution of CT scans without radiation exposure.

  • Is BoneMRI v1.6 compatible with all MRI systems, or does it need to be integrated with specific equipment?

    BoneMRI v1.6 is supplied as standalone software and requires integration with existing MRI systems capable of producing 3D gradient echo scans. While it is not limited to a specific MRI brand, compatibility depends on the system’s ability to generate the required scan type. The device itself does not include hardware components, so users must ensure their MRI equipment supports the necessary imaging protocols for proper functionality.

  • How is BoneMRI v1.6 classified, and what regulatory pathways does it follow for approval?

    BoneMRI v1.6 is classified as a Class II medical imaging software device under the Medical Device Regulation (MDR) and holds FDA 510(k) clearance (K230197). The clearance was granted as substantially equivalent to a predicate device and was reviewed by the Radiology Advisory Committee (RA). The regulatory route confirms it meets safety and performance standards for use in spine and pelvic imaging, though it does not carry sterility or MRI safety certifications.

  • Can BoneMRI v1.6 be reused or is it intended for single-use, and what are the storage requirements?

    BoneMRI v1.6 is not single-use or reusable—it is designed as a permanent software installation on compatible MRI systems. Since it is not sterile, no specific sterile storage requirements apply. However, users should follow standard IT and software maintenance protocols to ensure optimal performance, including regular updates and system backups, as outlined in the manufacturer’s instructions.

  • What anatomical regions does BoneMRI v1.6 focus on, and what precision can clinicians expect from its imaging?

    BoneMRI v1.6 is intended for spine and pelvic anatomy imaging in both adults and adolescents. The device provides sub-millimeter precision, enabling detailed visualization of bone density and structure in these regions. This precision is achieved through AI-driven conversion of MRI scans into HU-measured images, which closely replicate the density resolution of CT scans without radiation exposure.