510(k) · Cleared

Cleared

NEUROShield

K220034510(k) TraditionalCleared Sep 14, 2023617-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

In-Med Prognostics L3c · LLZ System, Image Processing, Radiological

Cleared on Sep 14, 2023 as substantially equivalent to K170981 (Cortechs Labs, Inc., 2017) after a 617-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.

Decided: Sep 14, 2023
Review: 617 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K061855 (2006). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK061855 NeuroquantCortechs Labs, Inc. · 2006
1 generation backK170981 NeuroQuantCortechs Labs, Inc. · 2017
This deviceK220034 NEUROShieldIn-Med Prognostics L3c · 2023
Descendant · cites it directly · 0 of its ownK252670 AlzevitaTopia Medtech Limited · 2025

Most influential descendants

Showing 1 of 1 · See all

K252670AlzevitaTopia Medtech Limited · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K061855	Neuroquant	Cortechs Labs, Inc.	2006	—
−1	K170981	NeuroQuant	Cortechs Labs, Inc.	2017	—
0 (this device)	K220034	NEUROShield	In-Med Prognostics L3c	2023	—
+1	K252670	Alzevita	Topia Medtech Limited	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K220034, 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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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
*	K170981	NeuroQuant Summary page 4 …duct Code QIH Classification Panel Radiology III. Predicate Device: Device NeuroQuant 510(k) Number K170981 Manufacturer CorTechs Labs, Inc Product Code: LLZ IV. Device Description: NEUROShieldTM…	Cortechs Labs, Inc.	2017	—

Also cleared against K170981: 13 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K252670	Alzevita	Topia Medtech Limited	2025	0

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 17 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K252670 (Topia Medtech Limited, 2025) has gone furthest, with 0 descendants of its own.
13 other devices also cite its predicate K170981.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The NEUROShield™ medical image processing software is intended for automatic labelling, visualization, and volumetric quantification of the Hippocampus brain structure from a set of MR images.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K220034 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220034: NEUROShield.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220034

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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