Key Features

  • MRI image enhancement

General Information

Product name

SubtleHD

Subspeciality

Abdomen, Breast, Cardiac, MSK, Neuro

Modality

MRI

Disease targeted

Performance validation dataset includes achilles rupture, autism with seizures, benign neoplasm, BPH, breast cancer, cancer, carcinoma, changes in vision, cognitive decline, cysts, elevated pancreatic blood levels, elevated PSA, encephalomyelitis, fracture, GI tract disease, headache/pain, headaches, headaches/dizziness, healthy, hearing loss/tumor follow-up, inflammation, injury, internal derangement, labral tear, loss of balance, mass, memory loss, migraines, neck/shoulder pain, neuromyelitis, numbness, osteosarcoma, pain, prostate cancer, radiculitis, sciatica, screening/breast cancer, screening/healthy, seizure, sprain, stroke, tumor follow-up/hearing loss, weakness, and unknown.

Main task

Not specified

Technical Specifications

Population

From 3 to 94 years old.

Patient population age

Adult, Elderly, Pediatric

Input

DIXON, DWI, FLAIR, GRE, MRA, PD, RADIAL, STIR, SWI, T1, T2, T2*, MIP protocols; AX, COR, and SAG orientations; 2D and 3D; 0.25T to 3.0T; up to 80% time reduction; Reconstruction Matrix up to 1344x1344; Major scanner vendors

Input format

DICOM

Output

Enhanced DICOMs that have been denoised and sharpened

Output format

DICOM

Integration

Not specified

Deployment

Not specified

Trigger for analysis

Not specified

Processing time

Not specified

Regulatory Information

CE Certification

Pathway:

MDR

Class:

Class IIa

Not verified by Health AI Register
FDA Certification

Pathway:

510(k) cleared

Class:

Class II

Verified by Health AI Register

Other certifications

Not specified

Market Presence

On market since

Not specified

AI Platforms

Not specified

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

Evidence & Research

No research papers or evidence available for this product.

Source: vendor | First published: Jul 29, 2025 | Last updated: Jul 29, 2025