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Morph

by BeauBrain Healthcare, Inc.

510(k) K260032

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK260032 Date13 May 2026ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 19 Sep 2026

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

Morph is a radiology AI device designed for the analysis and interpretation of medical imaging, specifically within the scope of neurological assessments. It leverages artificial intelligence to assist in detecting and evaluating patterns relevant to conditions such as dementia, supporting diagnostic workflows in clinical settings.

This device is supplied as a software-based solution, intended for use in radiology departments or imaging centers equipped with compatible imaging modalities. It operates as a reusable system, requiring no sterilization, and is classified under product code QIH with an FDA 510(k) clearance (K260032) for traditional review. Compliance with MRI safety standards is implied by its radiology-focused design, though explicit MRI compatibility details are not provided in the specifications.

Questions

AI-generated answers, 19 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 medical imaging does Morph analyze, and how does it assist in neurological assessments?

    Morph is specifically designed to analyze medical imaging within neurological assessments, focusing on conditions like dementia. It uses artificial intelligence to detect and evaluate patterns in imaging data, helping radiologists and clinicians streamline diagnostic workflows by providing AI-driven insights.

  • Is Morph a single-use or reusable device, and does it require sterilization?

    Morph is a reusable software-based solution and does not require sterilization. Since it operates as a digital system, it is not subject to sterilization processes like physical medical devices.

  • How is Morph supplied, and what kind of imaging equipment must be compatible with it?

    Morph is supplied as a software solution intended for use in radiology departments or imaging centers. It is designed to integrate with compatible imaging modalities commonly used for neurological assessments, though specific hardware requirements are not detailed beyond its radiology-focused design.

  • What regulatory pathway did Morph follow to gain clearance, and what does this imply about its safety standards?

    Morph received FDA clearance through a 510(k) submission under traditional review (K260032) and was determined to be substantially equivalent to a predicate device. This implies it meets FDA safety and effectiveness requirements for radiology AI devices, though explicit MRI compatibility details are not provided in the specifications.