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ProductsSubtleMR

Reviewed 8 Oct 2026

Completeness Strong (64%)

SubtleMR is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal MRI, or increase image sharpness for head MRI.

Supported by 1 paper

Key features

Image quality assessment

MRI image enhancement

General Information

Product name

SubtleMR

Modality

MR

Main task

Not specified

Subspeciality

MSK, Neuro

Disease targeted

Performance validation dataset includes Alzheimer's disease (AD), abdominal pain, benign fibrosis, brain cancer, brain tumor, breast cancer, calcific tendinitis, cerebral infarct, chronic hip and lower back pain, elevated prostate-specific antigen (PSA), GK follow-up, groin pain, head pressure, headache, healthy, hearing loss, lower back pain, lesion, lower abdominal pain, malignant neoplasm, mass, memory difficulties, migraine, mild cognitive impairment, Multiple Sclerosis (MS), motor vehicle accident, neoplasm, pain, pancreas cancer, pelvic pain, plantar fascia chronic tear, prostate cancer, r/o ACL tear, r/o MPFL rupture, right hip pain, right shoulder pain, stroke, trigeminal neuralgia, and tumor.

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIa

Not verified by Health AI Register

FDA Certification

Pathway:

510(k) cleared

Class:

Class II

FDA Number:

K191688

View FDA record

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

Technical Specifications

Patient population age

Adult, Pediatric

Input

2D, 3D, Field Strengths: 0.3T, 1.16T, 1.5T, 3.0T, Orientations: Axial, Coronal, Sagittal, Vendors: GE Medical Systems, Hitachi Medical Corporation, Philips Medical Systems, and Siemens.

Input format

DICOM

Output

Enhanced MR series

Output format

DICOM

Integration

Integration CIS (Clinical Information System), Integration in standard reading environment (PACS), Integration RIS (Radiological Information System), Integration via AI marketplace or distribution platform

Deployment

Cloud-based, Locally on dedicated hardware, Locally virtualized (virtual machine, docker)

Trigger for analysis

Automatically, right after the image acquisition, On demand, triggered by a user through e.g. a button click, image upload

Processing time

1 - 10 minutes

Population

Age from 14 to 86 years old.

Market Presence

On market since

09-2019

AI Platforms

Resellers

Not specified

Countries present

Not specified

Paying clinical customers

Not specified

Research/test users

Not specified

Pricing Information

Pricing model

Not specified

Based on

Not specified

First published: Jul 29, 2025 | Last updated: Oct 8, 2026