Key Features

  • Contrast image synthesis
  • MRI image enhancement

General Information

Product name

SubtleSYNTH

Subspeciality

Spine

Modality

MRI

Disease targeted

Performance validation dataset includes pathologies of normal, degenerative, infection, trauma, cord lesion (intramedullary neoplasm, intramedullary inflammatory lesion including MS and NMOSD, spinal cord infarct, compressive myelopathy), non-cord lesion (bony metastatic lesion, intradural extramedullary lesions including meningioma, schwannoma, neurofibroma, arachnoid cyst, arachnoiditis, epidural collection/mass including epidural lipomatosis), vascular (AVM, dAVF, cavernous malformation), and hemorrhage (intrathecal hematoma, subdural hematoma, epidural hematoma, intramedullary hematoma).

Main task

Not specified

Technical Specifications

Population

Not specified

Patient population age

Adult, Pediatric

Input

Sagittal T1 and T2 weighted spine MRI without contrast, field strength: 0.3T, 0.6T, 1.0T, 1.16T, 1.5T, and 3T, vendors: GE, Fonar, Siemens, Toshiba, Philips, and Hitachi

Input format

DICOM

Output

Synthetic STIR image

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, Image upload, On demand, Right after the image acquisition, Triggered by a user through e.g. a button click

Processing time

1 - 10 minutes

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.

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