510(k) · Cleared

Cleared

Accipiolx

K201310510(k) TraditionalCleared Aug 7, 202084-day reviewClass II21 CFR 892.2080

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

Maxq AL, Ltd. · QAS Radiological Computer-Assisted Triage And Notification Software

Cleared on Aug 7, 2020 as substantially equivalent to K182177 (Maxq-Al, Ltd., 2018) after an 84-day review. Its family tree reaches back 2 generations to 2018.

Decided: Aug 7, 2020
Review: 84 days
Class: Class II
Product code: QAS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to DEN170073 (2018). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
1 generation backK182177 AccipiolxMaxq-Al, Ltd. · 2018
This deviceK201310 AccipiolxMaxq AL, Ltd. · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	DEN170073	ContaCT	Viz.Al, Inc.	2018	—
−1	K182177	Accipiolx	Maxq-Al, Ltd.	2018	—
0 (this device)	K201310	Accipiolx	Maxq AL, Ltd.	2020	—

FIG. 1 — Lineage of K201310, 2018–2020Source: 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 QAS? 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 QAS device

#1 K203508 BriefCasescore 25.5 · 4 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
*	K182177	Accipiolx Summary page 4 …ry Class: Class II Regulatory Classification and Product Code: 21 C.F.R. § 892.2080; QAS Predicate Device: AccipioIx, K182177, Manufactured by MaxQ AI Device Description AccipioIx is a software device de…	Maxq-Al, Ltd.	2018	—

Also cleared against K182177: 3 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 2 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K182177.

How does its category compare?

All QAS devices

QAS Radiological Computer-Assisted Triage And Notification Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · QAS

15in 2025

2007high 15 (2022) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAS

101in 2025

2007high 136 (2024) · low 86 (2021)2026

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

Recalls per year · QAS

No recall names QAS since 2007.

Adverse event reports per year · QAS

No MAUDE report names QAS since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	3	—	0
2019	5	111	0
2020	12	112	0
2021	5	86	0
2022	15	116	0
2023	11	98	0
2024	12	136	0
2025	15	101	0
2026	11	104	—

What is it indicated for?

AccipioIx is a software workflow tool designed to aid in prioritizing the clinical assessment of adult non-contrast head CT cases with features suggestive of acute intracranial hemorrhage in the acute care environment. AccipioIx analyzes cases using an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. AccipioIx is not intended to direct…

Read the full statement (109 words)

AccipioIx is not intended to direct attention to specific portions of an image or to anomalies other than acute intracranial hemorrhage. Its results are not intended to be used on a stand-alone basis for clinical decision-making nor is it intended to rule out hemorrhage or otherwise preclude clinical assessment of CT cases.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201310: Accipiolx.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201310

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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