510(k) · Radiology

Opulus™ Lymphoma Precision

by Roche Molecular Systems, Inc.

Opulus™ Lymphoma Precision is an AI-enabled medical device from Roche Molecular Systems, Inc. that the U.S. FDA cleared through 510(k) K243863 on May 30, 2025. Its lead review panel is Radiology and its primary product code is QIH (Automated Radiological Image Processing Software).

See also FDA-cleared AI radiology devices in 2025, all FDA AI clearances in 2025, top radiology AI devices.

Key facts

Submission numberK243863
Pathway510(k)
Date of final decision
Company (FDA list)Roche Molecular Systems, Inc.
Lead review panelRadiology
Primary product codeQIH — Automated Radiological Image Processing Software
Applicant (openFDA)Roche Molecular Systems, Inc.
Applicant locationSanta Clara, CA, US
Device classClass 2
Regulation number21 CFR 892.2050
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Opulus™ Lymphoma Precision went through this pathway (K243863).

openFDA lists it as a Class 2 device under 21 CFR 892.2050. Class II devices are moderate risk and are subject to general and special controls.

Product code QIH covers 305 devices on the FDA AI list. By decision date, this device is #204 of 305 under that code. Roche Molecular Systems, Inc. has 1 AI-enabled device on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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