SubtleSYNTH (1.x)

Trade Name

SubtleSYNTH

Generic Name

Radiology DICOM image processing application software

Model / Reference

1.x

Primary DI / UDI-DI

00860000171229

Basic UDI-DI

08600001712SubtleSYNTH1KR

510(k) Number

K241329 ↗

FDA Product Code

QIH, LNH

EMDN Code

Z11030582 Radiology instruments - software accessories

GMDN Term

Radiology DICOM image processing application software

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 892.2050 510(k)GUDID

892.1000 GUDID

Special Device Type

Software

Market of Registration

Spain

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

Commercial Distribution

In Commercial Distribution

• SubtleALIGN 1.x

  Class II

  GUDID on market

• SubtleHD-CT (1.x)

  Class II

  FDA 510(k) K254120 Active Cleared 15 May 2026

• SubtleHD-PET (1.x)

  Class II

  CE/MDR FDA 510(k) K254013 Active Cleared 14 May 2026

• SubtlePET (Software as a Service for post-processing of Positron Emission Tomography data)

  Class IIa

  CE/MDR 28620157147 Active Valid to Jul 2028 GUDID on market

• SubtleREFORMAT (1.x)

  Class II

  FDA 510(k) K233699 Active Cleared 29 Apr 2024

• SubtlePET

  Class II

  FDA 510(k) K182336 Active Cleared 30 Nov 2018

See all devices from Subtle Medical, Inc. →

• What is the primary purpose of the SubtleSYNTH (1.x) software in a clinical setting?

  SubtleSYNTH (1.x) is designed to enhance MRI scan quality by reducing artifacts and improving diagnostic clarity. It functions as a post-processing tool, meaning it works on existing MRI images to sharpen details and refine visual output—without requiring changes to the original imaging hardware or protocols. This makes it particularly useful for radiologists who need clearer images to make more accurate diagnoses.

• Does SubtleSYNTH (1.x) require any additional hardware to operate, or can it be used with standard MRI systems?

  SubtleSYNTH (1.x) is a digital software solution that integrates with standard MRI systems without needing extra hardware. It is intended for use in radiology departments and MRI facilities, relying solely on existing imaging infrastructure to process and enhance scans. This makes it a flexible, hardware-independent tool for improving diagnostic imaging.

• Is SubtleSYNTH (1.x) meant for repeated use across multiple patients, or is it single-use per imaging session?

  SubtleSYNTH (1.x) is intended for single-use per imaging session. While the software itself can be reused across different patients, each session’s post-processing is considered a distinct application of the tool. This approach ensures optimal performance and avoids potential data carryover between patients, maintaining accuracy and compliance with regulatory standards.

• How is SubtleSYNTH (1.x) regulated, and what does that mean for its use in a clinical environment?

  SubtleSYNTH (1.x) holds both FDA 510(k) clearance and MDR compliance, confirming it meets regulatory standards for radiology software under product code QIH. This means it has undergone evaluation to ensure safety and effectiveness as a post-processing tool for MRI scans, allowing clinicians to trust its performance in improving diagnostic clarity while adhering to established medical device regulations.

• Since SubtleSYNTH (1.x) is software, does it have any sterility requirements or special handling instructions?

  No, SubtleSYNTH (1.x) does not have sterility requirements because it is a digital solution, not a physical device that comes into direct contact with patients. However, it should be used in a controlled environment, such as a radiology department, where data integrity and security are maintained. Proper software updates and system maintenance are recommended to ensure optimal performance.