510(k) · Cleared

Cleared

Synq Software Version 1.3

K232981510(k) TraditionalCleared Oct 11, 202320-day reviewClass II21 CFR 892.1000

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

Synaptive Medical, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Oct 11, 2023 as substantially equivalent to K200327 (Synaptive Medical, Inc., 2020) after a 20-day review. Its family tree reaches back 12 generations to 1997. 5 of the 28 devices in its family, counting itself, have a Class I recall.

Decided: Oct 11, 2023
Review: 20 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 12 generations to K971684 (1997). 27 ancestors in all, the oldest K962061 (1996). No later device cites it as a predicate yet. 5 of the 28 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
8 generations between
3 generations backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
2 generations backK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012 · Recalled
1 generation backK200327 EvrySynaptive Medical, Inc. · 2020
This deviceK232981 Synq Software Version 1.3Synaptive Medical, Inc. · 2023

Show all 12 generations

Root · 12 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
11 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
10 generations backK041112 Magnetom Espree SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
9 generations backK052164 Magnetom Systems with Software Syngo MR 2006ASiemens Medical Solutions USA, Inc. · 2005
8 generations backK062454 Magnetom Systems - I-Class and T-Class ReleasesSiemens Medi Cal Solutions, Inc. · 2006
7 generations backK072237 Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · Recalled (Class I)
6 generations backK081028 Signa 3.0T MR750 SystemGe Medical Systems, LLC · 2008 · Recalled
5 generations backK083147 Discovery MR450Ge Medical Systems, LLC · 2008 · Recalled
4 generations backK091536 Optima MR450WGe Medical Systems, LLC · 2009 · Recalled
3 generations backK103327 Discovery MR750W 3.0TGe Healthcare Japan Corporation · 2011 · Recalled
2 generations backK121676 1.5T Signa HDXT 3.0T Signa HDXT Signa VibrantGe Medical Systems, LLC · 2012 · Recalled
1 generation backK200327 EvrySynaptive Medical, Inc. · 2020
This deviceK232981 Synq Software Version 1.3Synaptive Medical, Inc. · 2023

Class I recalls in this family

K041476 GE Signa Excite 1.5T MR System, GE Signa Excite…4 generations back · 2004
K072237 Magnetom Verio5 generations back · 2007
K030874 GE 3.0T Signa Infinity Twinspeed with Excite MR…5 generations back · 2003
K013636 Signa Infinity MR System with Excite Technology5 generations back · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−12	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−11	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−10	K041112	Magnetom Espree System	Siemens Medical Solutions USA, Inc.	2004	4
−9	K052164	Magnetom Systems with Software Syngo MR 2006A	Siemens Medical Solutions USA, Inc.	2005	—
−8	K062454	Magnetom Systems - I-Class and T-Class Releases	Siemens Medi Cal Solutions, Inc.	2006	—
−7	K072237	Magnetom Verio	Siemens Medical Solutions USA, Inc.	2007	Class I
−6	K081028	Signa 3.0T MR750 System	Ge Medical Systems, LLC	2008	11
−5	K083147	Discovery MR450	Ge Medical Systems, LLC	2008	10
−4	K091536	Optima MR450W	Ge Medical Systems, LLC	2009	8
−3	K103327	Discovery MR750W 3.0T	Ge Healthcare Japan Corporation	2011	6
−2	K121676	1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant	Ge Medical Systems, LLC	2012	10
−1	K200327	Evry	Synaptive Medical, Inc.	2020	—
0 (this device)	K232981	Synq Software Version 1.3	Synaptive Medical, Inc.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	2	0
2001	4	1
2002	2	1
2003	1	1
2004	1	1
2005	3	0

FIG. 1 — Lineage of K232981, 1997–2023Source: 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.

5 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 LNH device

#1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 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
*	K200327	Evry Summary page 4 …21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code IK200327 Ivr ZIN I Device Descripti…	Synaptive Medical, Inc.	2020	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (5 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.

K041476GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR SystemGe Medical Systems, LLC · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K072237Magnetom VerioSiemens Medical Solutions USA, Inc. · 2007 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K030874GE 3.0T Signa Infinity Twinspeed with Excite MR SystemGeneral Electric Co. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
K013636Signa Infinity MR System with Excite TechnologyGE Medical Systems · 2002 · 5 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
K0122001.5T Infinity Twinspeed MR SystemGE Medical Systems · 2001 · 6 generations back · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
19 of the 27 ancestors have a recall of any class; 5 have a Class I recall.

How does its category compare?

All LNH devices

LNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · LNH

26in 2025

2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007high 140 (2015) · low 35 (2007)2026

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

Recalls per year · LNH

8in 2025

2007high 71 (2018) · low 0 (2017)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · LNH

1,263in 2025

2007high 1,263 (2025) · low 84 (2021)2025

MAUDE reports naming product code LNH, 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	12	35	25	114
2008	19	53	12	167
2009	17	70	7	194
2010	12	94	17	165
2011	16	81	11	182
2012	22	89	5	170
2013	19	108	2	107
2014	17	108	13	119
2015	19	140	12 (2)	113
2016	20	108	1	135
2017	18	98	0	121
2018	29	128	71	158
2019	26	62	5	158
2020	32	121	4	98
2021	27	87	41	84
2022	30	74	13	138
2023	30	124	10 (1)	159
2024	26	104	4	281
2025	26	122	8 (5)	1,263
2026	24	126	43	—

What is it indicated for?

The Synq Software is indicated for use in conjunction with Synq, a magnetic resonance diagnostic device (MRDD) that produces axial, sagittal, coronal, and oblique cross-sectional images and displays the internal structure and/or function of the head. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232981 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232981: Synq Software Version 1.3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232981

Report an extraction error

Are you the manufacturer?

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