510(k) · Cleared

Cleared

Anatomark Noninvasive Head Reference System

K981398510(k) TraditionalCleared Jun 1, 199845-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

Interneuron Pharmaceuticals, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Jun 1, 1998 as substantially equivalent to K881131 (Sandstrom Trade & Technology, Inc., 1988) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1988.

Decided: Jun 1, 1998
Review: 45 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K881131 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881131 The Laitinen Stereotactic SystemSandstrom Trade & Technology, Inc. · 1988
This deviceK981398 Anatomark Noninvasive Head Reference SystemInterneuron Pharmaceuticals, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881131	The Laitinen Stereotactic System	Sandstrom Trade & Technology, Inc.	1988	—
0 (this device)	K981398	Anatomark Noninvasive Head Reference System	Interneuron Pharmaceuticals, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K981398, 1988–1998Source: 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 LNH? 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

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What was it cleared against? (2)

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
*	K881131	The Laitinen Stereotactic System Summary page 1 …E DEVICES The AnatoMark Noninvasive Head Reference System is an accessory to MR devices (21 CFR 892.1000). It shares some features with the Laitinen Stereoadapter 5000 (K881131), cleared as a stereotaxic instrument (21 CFR 882.4560), and the Codman Fiducial Marker System (K953568), cleared as a radiograph…	Sandstrom Trade & Technology, Inc.	1988	—
*	K953568	Codman Fiducial Marker System Summary page 1 …0). It shares some features with the Laitinen Stereoadapter 5000 (K881131), cleared as a stereotaxic instrument (21 CFR 882.4560), and the Codman Fiducial Marker System (K953568), cleared as a radiographic film marker (21 CFR 892.1640). DEVICE DESCRIPTION The AnatoMark Noninvasive Head Reference System i…	Codman & Shurtleff, Inc.	1996	—

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?

None of the 2 ancestors has a 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.

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 AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient’s cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and 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/K981398 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981398: Anatomark Noninvasive Head Reference System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981398

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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