SubtleHD-CT (1.x)
by Subtle Medical, Inc. United States 510(k)
510(k) K254120
Product code QIH
Overview
The SubtleHD-CT (1.x) is an AI-powered post-processing software designed to enhance computed tomography (CT) image quality. It reduces noise and improves low-contrast detectability, thereby increasing diagnostic confidence without requiring modifications to existing CT or PET/CT scanners. Classified as a radiology device, it leverages deep learning algorithms to refine image clarity and structural detail.
This software is supplied as a digital solution for integration with compatible CT systems, requiring no physical installation or sterility considerations. It operates as a reusable, non-invasive tool, compatible with standard MRI-safe environments. The device holds FDA 510(k) clearance (K254120) under the Traditional pathway, categorized under product code QIH, and is intended for use in radiology workflows. Storage and usage adhere to standard IT and imaging system protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK254120 | Date15 May 2026 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QIH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
From the manufacturer
SubtleHD™ (CT) Reduces noise and improves low contrast detectability of CT images on any existing CT or PET/CT scanner, improving image quality and diagnostic confidence.
Using Subtle Medical, we are able to maintain superior image quality of our accelerated protocols.
Other devices from Subtle Medical, Inc.
Questions
What is the SubtleHD-CT (1.x) designed to improve in CT imaging?
The SubtleHD-CT (1.x) is an AI-powered post-processing software specifically engineered to enhance CT image quality by reducing noise and improving low-contrast detectability. This refinement increases diagnostic confidence for radiologists by sharpening structural details without requiring modifications to the original CT scanner or PET/CT system.
How is the SubtleHD-CT (1.x) supplied and does it require physical installation?
The SubtleHD-CT (1.x) is supplied as a digital solution, meaning it is delivered via software integration rather than physical hardware. No physical installation is required, and it operates as a reusable, non-invasive tool that can be seamlessly integrated into compatible CT systems without altering existing equipment.
Is the SubtleHD-CT (1.x) single-use or reusable, and what sterility considerations apply?
The SubtleHD-CT (1.x) is a reusable software solution, meaning it is not designed for single-use disposal. Since it is a digital tool with no physical components that come into contact with patients, traditional sterility considerations (such as sterilization or packaging) do not apply. Compliance with standard IT and imaging system protocols ensures proper usage and maintenance.
What regulatory pathway and clearance does the SubtleHD-CT (1.x) hold?
The SubtleHD-CT (1.x) has received FDA 510(k) clearance under the Traditional pathway, with clearance number K254120. It is classified under product code QIH and is intended for use in radiology workflows, adhering to established regulatory standards for radiology devices.
Can the SubtleHD-CT (1.x) be used in MRI-safe environments?
Yes, the SubtleHD-CT (1.x) is compatible with standard MRI-safe environments. As a software-based solution, it does not introduce electromagnetic interference or physical risks associated with MRI procedures, making it suitable for integration into radiology workflows where MRI compatibility is a consideration.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K254120