Cleerly LABS

FDA 510(k) K260588 · Cleerly, Inc.

Substantially Equivalent

510(k) numberK260588

Submission

Device name
Cleerly LABS
Applicant
Cleerly, Inc.
Denver, CO, US
Received
February 20, 2026
Decision date
July 29, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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More from Provect.AI

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K231335Cleerly ISCHEMIAQXZ · Traditional 09/08/2023SE
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Questions and answers

When was Cleerly LABS cleared by the FDA?

Cleerly LABS (K260588) received a 510(k) decision of Substantially Equivalent on July 29, 2026, 159 days after the submission was received.

What is the product code of K260588?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.