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ProductsSubtleHD

Vendor source

Reviewed 11 May 2026

Completeness Good (50%)

SubtleHD is an image processing software that can be used for image enhancement of all body parts MRI images. It can be used for noise reduction and increasing image sharpness.

No papers to support — we monitor for new evidence.

Key features

MRI image enhancement

General Information

Product name

SubtleHD

Modality

MR

Main task

Not specified

Subspeciality

Multiple

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.

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:

K243250

View FDA record

Verified by Health AI Register

Other certifications

Not specified

Evidence & Research

No research papers or evidence on file yet.

The registry monitors publications for new evidence.

Technical Specifications

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

Population

From 3 to 94 years old.

Market Presence

On market since

Not specified

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

Source: Vendor | First published: Jul 29, 2025 | Last updated: May 11, 2026