510(k) · Cleared

Cleared

Neuro.Al Algorithm

K200750510(k) SpecialCleared Nov 6, 2020228-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

Terarecon,Inc. · LLZ System, Image Processing, Radiological

Cleared on Nov 6, 2020 as substantially equivalent to K131447 (Terarecon,Inc., 2013) after a 228-day review. Its family tree reaches back 11 generations to 1997. 2 of the 81 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Nov 6, 2020
Review: 228 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 11 generations to K971684 (1997). 79 ancestors in all, the oldest K913770 (1991). 1 later device descends from it, 1 citing it directly. 2 of the 81 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
7 generations between
3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
2 generations backK121459 Syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2012
1 generation backK131447 Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013
This deviceK200750 Neuro.Al AlgorithmTerarecon,Inc. · 2020
Descendant · cites it directly · 0 of its ownK220349 TeraRecon NeuroTerarecon,Inc. · 2022

Show all 11 generations

Root · 11 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
10 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
9 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
8 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
7 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
6 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
5 generations backK082427 Syngo MR B17Siemens Medical Solutions USA, Inc. · 2008
4 generations backK101347 Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · Recalled (Class I)
3 generations backK111242 Magnetom Aera and Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2011 · Recalled
2 generations backK121459 Syngo.MR NeurologySiemens Medical Solutions USA, Inc. · 2012
1 generation backK131447 Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013
This deviceK200750 Neuro.Al AlgorithmTerarecon,Inc. · 2020

Class I recalls in this family

K101347 Magnetom Aera; Magnetom Skyra4 generations back · 2010
K072237 Magnetom Verio4 generations back · 2007

Most influential descendants

Showing 1 of 1 · See all

K220349TeraRecon NeuroTerarecon,Inc. · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−11	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−10	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−9	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−8	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−7	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−6	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−5	K082427	Syngo MR B17	Siemens Medical Solutions USA, Inc.	2008	—
−4	K101347	Magnetom Aera; Magnetom Skyra	Siemens Medical Solutions USA, Inc.	2010	Class I
−3	K111242	Magnetom Aera and Magnetom Skyra	Siemens Medical Solutions USA, Inc.	2011	3
−2	K121459	Syngo.MR Neurology	Siemens Medical Solutions USA, Inc.	2012	—
−1	K131447	Intuition - Tda, Tva, Parametric Mapping	Terarecon,Inc.	2013	—
0 (this device)	K200750	Neuro.Al Algorithm	Terarecon,Inc.	2020	—
+1	K220349	TeraRecon Neuro	Terarecon,Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1994	2	0
1995	2	0
1996	3	0
1997	4	0
1998	2	0
1999	3	0
2000	5	0
2001	12	0
2002	3	0
2003	4	0
2004	6	0
2005	4	0
2006	5	0
2007	3	0
2008	4	0
2009	2	0
2010	1	0
2011	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K200750, 1997–2022Source: 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.

2 devices in this family have a Class I recall. 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

Get a 510(k) Report

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
*	K131447	Intuition - Tda, Tva, Parametric Mapping Summary page 4 …LLZ – System, Image Processing, Radiological 3. PREDICATE DEVICE Predicate Device iNtuition-TDA, TVA and Parametric Mapping (K131447) Reference Device iNtuition system (K121916) 4. DEVICE DESCRIPTION The Neuro.AI Algorithm is a modifi…	Terarecon,Inc.	2013	—
†	K121916	Intuition	Terarecon,Inc.	2013	1

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
K220349	TeraRecon Neuro	Terarecon,Inc.	2022	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K101347Magnetom Aera; Magnetom SkyraSiemens Medical Solutions USA, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
23 of the 79 ancestors have a recall of any class; 2 have a Class I recall.
Of its descendants, K220349 (Terarecon,Inc., 2022) has gone furthest, with 0 descendants of its own.

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. 2020, 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 Neuro.Al Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians. The Neuro.Al Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows® executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via…

Read the full statement (266 words)

The Neuro.Al Algorithm is an algorithm for use by trained professionals, including but not limited to physicians, surgeons and medical clinicians.

The Neuro.Al Algorithm is a standalone image processing software device that can be deployed as a Microsoft Windows® executable on off-the-shelf hardware or as a containerized application (e.g., a Docker container) that runs on off-the-shelf hardware or on a cloud platform. Data and images are acquired via DICOM compliant imaging devices. DICOM results may be exported, combined with or utilized by other DICOM-compliant systems and results.

The Neuro.Al algorithm provides analysis capabilities for static, functional, dynamic and derived imaging datasets acquired with CT or MRI. It can be used for the analysis of dynamic brain perfusion image data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to brain tissue perfusion, vascular assessment and tissue blood volume and other parametric maps with or without the ventricles included in the calculation. The algorithm also includes volume reformat in various orientations, rotational MIP 3D batch while removing the skull. This “tumble view” allows qualitative review of vascular structure in direct correlation to the perfusion maps for comprehensive review.

The results of the Neuro.Al Algorithm can be delivered to the end-user through image viewers such as TeraRecon’s Aquarius iNtuition system, TeraRecon’s Northstar Al Results Explorer, or other image viewing systems like PACS that can support DICOM results generated by Neuro. Al

The Neuro.Al Algorithm results are designed for use by trained healthcare professionals and are intended to assist the physician in diagnosis, who is responsible for making all final patient management decisions.

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/K200750 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200750: Neuro.Al Algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200750

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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