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ProductsSubtlePET

Reviewed 11 May 2026

Completeness Good (58%)

SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-Choline, 18F-DCFPyL, Ga-68 Dotatate, and G-68a PSMA radiotracer PET images (including PET/CT and PET/MRI).

No papers to support — we monitor for new evidence.

General Information

Product name

SubtlePET

Modality

PET

Main task

Not specified

Subspeciality

Multiple

Disease targeted

Disease(s) imaged with PET

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:

K211964

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

25%, 33%, 50% acceleration; GE, Philips, Siemens

Input format

DICOM

Output

Enhanced PET 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

Ages from 2 to 86 years old, regular and high BMI

Market Presence

On market since

11-2018

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: May 11, 2026

SubtlePET - Subtle Medical