510(k) · Cleared

Cleared

Opulus™ Lymphoma Precision

K243863510(k) TraditionalCleared May 30, 2025164-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Roche Molecular Systems, Inc. · QIH Automated Radiological Image Processing Software

Cleared on May 30, 2025 as substantially equivalent to K221738 (Neosoma, Inc., 2022) after a 164-day review. Its family tree reaches back 3 generations to 2006.

Decided: May 30, 2025
Review: 164 days
Class: Class II
Product code: QIH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K061855 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
2 generations backK170981 NeuroQuantCortechs Labs, Inc. · 2017
1 generation backK221738 NS-HGlioNeosoma, Inc. · 2022
This deviceK243863 Opulus™ Lymphoma PrecisionRoche Molecular Systems, Inc. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K061855	Neuroquant	Cortechs Labs, Inc.	2006	—
−2	K170981	NeuroQuant	Cortechs Labs, Inc.	2017	—
−1	K221738	NS-HGlio	Neosoma, Inc.	2022	—
0 (this device)	K243863	Opulus™ Lymphoma Precision	Roche Molecular Systems, Inc.	2025	—

FIG. 1 — Lineage of K243863, 2006–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QIH device

#1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K221738	NS-HGlio Summary page 5 …21 CFR 892.2050 Regulatory Class II Product Codes QIH, Automated Radiological Image Processing Software NS-HGlio, K221738 Predicate Device 1. DEVICE DESCRIPTION Opulus™ Lymphoma Precision is an assistive tool which can be used by…	Neosoma, Inc.	2022	—

Also cleared against K221738: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.1 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K221738.

How does its category compare?

All QIH devices

QIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · QIH

94in 2025

2007high 94 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QIH

150in 2025

2007high 151 (2023) · low 125 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QIH

1so far in 2026, the most since 2007

2007high 1 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · QIH

4in 2025

2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	0
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	2	—	0	0
2020	11	145	0	0
2021	19	125	0	0
2022	25	134	0	0
2023	45	151	0	0
2024	64	141	0	2
2025	94	150	0	4
2026	78	130	1	—

What is it indicated for?

Opulus™ Lymphoma Precision is a software device that uses a machine learning-based algorithm to automate segmentation and visualization of lesions along with automation of measurement of total metabolic tumor volume within whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. Opulus™ Lymphoma Precision is used to assist trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions in a…

Read the full statement (115 words)

Opulus™ Lymphoma Precision is used to assist trained interpreting physicians with visualization of suspected lesions and calculation of total volume of all lesions in a body. This information can be used in addition to the standard of care image interpretation of FDG-PET/CT scans. Opulus™ Lymphoma Precision annotated images can be reviewed by an appropriately trained physician.

The algorithm is assistive, and requires a radiologist review, who will make the final decision on FDG-PET/ CT image interpretation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243863 · printed Nov 5, 2026

Cite this page

510(k) Report. “K243863: Opulus™ Lymphoma Precision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243863

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026