SubtleHD-PET (1.x)

510(k) Number

K254013 ↗

FDA Product Code

LLZ

Device Class

Class II

Regulation

21 CFR Part 892.2050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• SubtleALIGN 1.x

  Class II

  GUDID on market

• SubtleHD-CT (1.x)

  Class II

  FDA 510(k) K254120 Active Cleared 15 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

• SubtleMR (2.3.x)

  Class II

  FDA 510(k) K223623 Active Cleared 11 May 2023

See all devices from Subtle Medical, Inc. →

• How is the SubtleHD-PET (1.x) software delivered and what systems does it work with?

  The SubtleHD-PET (1.x) is supplied as a digital download, meaning it is not shipped physically but installed directly onto compatible systems. It is designed to function as a post-processing tool on MRI and PET imaging systems, enhancing PET scan outputs without requiring additional hardware. This makes it a flexible solution for radiology departments already equipped with these imaging modalities.

• Is the SubtleHD-PET (1.x) intended for single-use or repeated use across multiple patients?

  Since the SubtleHD-PET (1.x) is an AI-powered software solution supplied as a digital download, it is not designed for single-use. Instead, it is intended for repeated use across multiple patients, as it operates on imaging systems to refine and optimize PET scans in a radiology setting. The software remains installed on the system and can be applied to new scans as needed.

• What regulatory pathways does the SubtleHD-PET (1.x) follow in the U.S. and Europe?

  In the U.S., the SubtleHD-PET (1.x) has received FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed predicate device. For European compliance, it adheres to the EU Medical Device Regulation (MDR), ensuring it meets the stringent requirements for software-as-a-medical-device applications in the EU market.

• Does the SubtleHD-PET (1.x) require any special handling or storage conditions?

  As a digital software solution, the SubtleHD-PET (1.x) does not require physical storage or special handling beyond standard IT protocols for medical imaging software. It is installed on compatible MRI and PET systems, so compliance with the manufacturer’s installation and maintenance guidelines—such as system updates and data security—is the primary consideration. No additional sterility or environmental storage conditions apply.