SubtleHD-PET clearance targets low-count PET scans
Subtle Medical said the software can enhance PET images from accelerated acquisitions and supports PET/CT and PET/MR systems across FDA-approved radiotracers.
Subtle Medical has received FDA clearance for SubtleHD-PET, an AI image-enhancement software for PET imaging. FDA clearance record K254013 lists the device as SubtleHD-PET 1.x, with a substantially equivalent decision dated May 14, 2026.
The software is intended to improve PET image quality from accelerated low-count PET acquisitions, according to Subtle Medical’s announcement. The company said the product works across PET/CT and PET/MR systems.
Subtle Medical said SubtleHD-PET can support PET acquisition-time reductions of up to 75% on existing scanners. The company also said the software supports all FDA-approved radiotracers, including molecular imaging agents beyond traditional 18F-FDG imaging.
The software includes adjustable denoising levels that can be set based on radiologist preference, according to the company. It also uses anatomical CT data to improve PET reconstruction quality and quantitative consistency.
Subtle Medical positioned the clearance as an expansion beyond its existing SubtlePET platform. The company said its imaging tools are deployed on more than 1,300 scanners worldwide.
The broader portfolio includes AI imaging products across MRI, PET, and CT. Subtle Medical said SubtleHD-PET is part of a planned AI imaging hub intended to support image acceleration, enhancement, and workflow organization across modalities.
Company:Subtle Medical
Sources
- SubtleHD-PET (1.x), K254013. Regulatory filing
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