Radiology AI Directory

Documented family

BoneMRI

This is a documented BoneMRI product-family relationship. Each linked FDA submission remains a separate record with its own intended use, evidence, implementation facts, and limitations.

Choose the exact submission below before comparing evidence or opening a checklist. The proposed installed version and licensed modules still need confirmation with the supplier.

All documented families · Evaluation pilot

Documented product family

Related FDA records

These links identify a sourced product-family relationship. They do not transfer evidence, metrics, clearance scope, compatibility, pricing, or availability between submissions.

BoneMRI

This is a documented BoneMRI product-family relationship. Each linked FDA submission remains a separate record with its own intended use, evidence, implementation facts, and limitations.

MRIguidance's official BoneMRI page is a current product-family source. The individual FDA decision materials identify the named submissions below. The family source does not establish feature parity, supersession, or current commercial availability for either submission.

Family source
  1. Related FDA recordBoneMRI v1.6 (K230197)

    BoneMRI v1.6 release reviewed in K230197

    FDA decision: 2023-02-22 · record reviewed 2026-09-07
    FDA source
  2. Related FDA recordBoneMRI (K233030)

    BoneMRI release reviewed in K233030

    FDA decision: 2024-03-01 · record reviewed 2026-09-07
    FDA source
Latest FDA decision among these records
K233030 · 2024-03-01. This is the latest FDA decision date among the mapped records only. It is not a statement that K233030 supersedes K230197.
Latest documented release
No source reviewed for this mapping establishes a current commercial release chronology beyond the individual FDA records.
Current commercial availability
The reviewed materials do not establish current commercial availability or an installed version.