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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

FDA Clears Subtle Medical's SubtleHD(CT), Its First AI Software for CT

The image enhancement software, cleared under 510(k) K254120, is meant to cut noise and improve low-contrast detectability on CT scans, including on older scanners.

By News DeskJune 10, 20262 min read
The open gantry of a CT scanner showing its internal ring of components, next to an open electrical cabinet in a hospital room.
A CT scanner with its covers removed during installation at a hospital in Nyeri County, Kenya. Not a Subtle Medical product; SubtleHD(CT) is software. Obynel, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA cleared510(k) · K254120FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • Subtle Medical announced on June 10, 2026, that the FDA cleared SubtleHD(CT), AI software that processes CT images to reduce noise.
  • The FDA's 510(k) database lists SubtleHD-CT (1.x) as K254120, received December 19, 2025, and decided May 15, 2026.
  • It is the Menlo Park company's first CT product and its 11th FDA-cleared product, the company said.

Subtle Medical said on June 10 that the U.S. Food and Drug Administration has cleared SubtleHD(CT), artificial intelligence software that processes computed tomography images to reduce noise and improve low-contrast detectability. The Menlo Park, Calif., company said in its announcement that the product is its first for CT and its 11th to receive FDA clearance.

The FDA's 510(k) database lists the device as SubtleHD-CT (1.x), number K254120. The agency received the submission on December 19, 2025, and found it substantially equivalent to a device already on the market on May 15, 2026. It is classified as automated radiological image processing software, product code QIH, and the record shows no predetermined change control plan.

Aimed at mixed scanner fleets

The software is designed to enhance image quality after a scan is taken rather than requiring new hardware. Subtle said hospitals and imaging centers face pressure to deliver consistent image quality across diverse scanner fleets, including older systems still in use, as imaging volumes grow. SubtleHD(CT) is meant to fit into existing workflows, the company said.

"Healthcare organizations are looking for ways to improve imaging performance while maximizing the value of the infrastructure they already have," said Ohad Arazi, Subtle Medical's chief executive. "With SubtleHD(CT), we're extending our expertise in AI-powered image enhancement to CT and taking another step toward our vision of helping providers enhance image quality across the imaging enterprise."

The announcement does not include performance data, and the FDA database entry does not report test results. Diagnostic Imaging, which reported the clearance the same day, attributed the description of the product's noise reduction and image quality to the company.

A growing multi-modality portfolio

SubtleHD(CT) joins the company's MRI and PET products, including SubtleHD(MR), SubtleHD(PET), SubtleSYNTH and SubtleALIGN. The company said its technology is deployed on more than 1,300 scanners worldwide and described its goal as a vendor-neutral imaging hub that works across modalities and equipment makers.

The FDA database also lists a separate clearance for SubtleHD-PET (1.x), K254013, with a decision date of May 14, 2026, according to the agency's openFDA device records.

Subtle did not disclose pricing or availability dates for the CT software in the announcement.

Sources

  1. Subtle Medical Receives FDA Clearance for SubtleHD(CT), Expanding AI-Powered Image Enhancement into CT Imaging, Subtle Medical, June 10, 2026
  2. 510(k) Premarket Notification K254120: SubtleHD-CT (1.x), U.S. Food and Drug Administration, May 15, 2026
  3. openFDA 510(k) records: Subtle Medical, January-July 2026, U.S. Food and Drug Administration (openFDA), May 15, 2026
  4. FDA Clears AI-Powered Software for Improving Low-Contrast CT Detection, Diagnostic Imaging, June 10, 2026