Cleerly LABS (v2.0)

FDA 510(k) K242338 · Cleerly, Inc.

Substantially Equivalent

510(k) numberK242338

Submission

Device name
Cleerly LABS (v2.0)
Applicant
Cleerly, Inc.
Denver, CO, US
Received
August 7, 2024
Decision date
March 7, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIH – Automated Radiological Image Processing Software
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code.

Other 510(k)s with product code QIH

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K261795Quicktome Software SuiteQIH · Traditional Omniscient Neurotechnology Pty, Ltd.09/10/2026SE
K2608794DMQIH · Traditional Invia, LLC09/10/2026SE
K251417ReVISION 2QIH · Traditional Argus Cognitive, Inc.09/09/2026SE
K260525NextMR SpineQIH · Traditional MRI2CT, Inc.09/04/2026SE
K260811Heartvue.ProtonQIH · Traditional Heartvue.ai, Inc.08/26/2026SE
K261595Ceevra Reveal 4QIH · Traditional Ceevra, Inc.08/25/2026SE
K262127DS Core CBCT AnatomyQIH · Traditional Dentsply Sirona08/21/2026SE
K260584BoneMRIQIH · Traditional Mriguidance B.V.08/21/2026SE
K261641Lower Limb AI (LLAI)QIH · Traditional AI Planning Logic, Inc.08/18/2026SE
K253794Prostate CoreQIH · Traditional Lucida Medical, Ltd.08/10/2026SE

More from Lucida Medical, Ltd.

510(k)DeviceDecision
K261210Cleerly PlaqueQIH · Traditional 07/29/2026SE
K260588Cleerly LABSLLZ · Traditional 07/29/2026SE
K231335Cleerly ISCHEMIAQXZ · Traditional 09/08/2023SE
K202280Cleerly Labs v2.0LLZ · Traditional 10/02/2020SE
K190868Cleerly LabsLLZ · Traditional 11/05/2019SE

Questions and answers

When was Cleerly LABS (v2.0) cleared by the FDA?

Cleerly LABS (v2.0) (K242338) received a 510(k) decision of Substantially Equivalent on March 7, 2025, 212 days after the submission was received.

What is the product code of K242338?

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