510(k) · Cleared

Cleared

Hydrogen Spectroscopy Option-Probe #M1040HS/HT

K930265510(k) TraditionalCleared Apr 25, 1995826-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

GE Medical Systems · LNI System, Nuclear Magnetic Resonance Spectroscopic

Cleared on Apr 25, 1995 after an 826-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided: Apr 25, 1995
Review: 826 days
Class: Class II
Product code: LNI
Recalls: None
Predicates: 0

32 later devices descend from it, 5 citing it directly.

This deviceK930265 Hydrogen Spectroscopy Option-Probe #M1040HS/HTGE Medical Systems · 1995
Descendant · cites it directly · 21 of its ownK011604 Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MriGe Medical Systems, Inc. · 2001
Descendant · 2 generations on · 19 of its ownK031350 3TP Software Option3tp, LLC · 2003 · Recalled
Descendant · 3 generations on · 17 of its ownK041286 Dynacad V1.0Mri Devices Corp. · 2004
Descendant · 2 generations on · 10 of its ownK050862 3TP Workspace3tp, LLC · 2005 · Recalled
Descendant · 3 generations on · 9 of its ownK081556 Cadstream, Version 5.0Confirma, Inc. · 2009

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

1997high 4 (2009) · low 0 (1998)2026

Most influential descendants

Showing 5 of 32 · See all

K011604Prostate Spectroscopy and Imaging Exam (Prose) Software Option for MriGe Medical Systems, Inc. · 2001 · cites it directly21descendants
K0313503TP Software Option3tp, LLC · 2003 · 2 generations on19descendants
K041286Dynacad V1.0Mri Devices Corp. · 2004 · 3 generations on17descendants
K0508623TP Workspace3tp, LLC · 2005 · 2 generations on10descendants
K081556Cadstream, Version 5.0Confirma, Inc. · 2009 · 3 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930265	Hydrogen Spectroscopy Option-Probe #M1040HS/HT	GE Medical Systems	1995	—
+1	K011604	Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri	Ge Medical Systems, Inc.	2001	—
+2	K031350	3TP Software Option	3tp, LLC	2003	1
+3	K041286	Dynacad V1.0	Mri Devices Corp.	2004	—
+2	K050862	3TP Workspace	3tp, LLC	2005	1
+3	K081556	Cadstream, Version 5.0	Confirma, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	2	0
2001	1	0
2003	1	0
2004	1	0
2005	2	0
2007	1	0
2008	1	0
2009	4	0
2010	1	0
2014	1	0
2017	1	0
2018	2	0
2019	2	0
2020	2	0
2021	2	0
2023	1	0
2024	3	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K930265, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (32)

See all 32

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011604	Prostate Spectroscopy and Imaging Exam (Prose) Software Option for Mri	Ge Medical Systems, Inc.	2001	21
K991568	MR Spectroscopy Package	Philips Medical Systems (Cleveland), Inc.	1999	6
K073425	Modification to Aurora Mri System	Aurora Imaging Technology, Inc.	2008	0
K983139	Signa 1.5T Phosphorus (P) Transmit/Receive Flex Coil	GE Medical Systems	1999	0
K970005	Gyrex 2T-Prestige	Elscint, Inc.	1997	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?

Of its descendants, K011604 (Ge Medical Systems, Inc., 2001) has gone furthest, with 21 descendants of its own.

How does its category compare?

All LNI devices

LNI System, Nuclear Magnetic Resonance Spectroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LNI

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNI

Too few LNI 510(k)s in any year since 2007 to give a median.

Recalls per year · LNI

12in 2024

2007high 12 (2024) · low 0 (2007)2026

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

Adverse event reports per year · LNI

1in 2025

2007high 7 (2012) · low 0 (2007)2025

MAUDE reports naming product code LNI, 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	1	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	1	—	0	0
2011	0	—	0	1
2012	0	—	0	7
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	1
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	1	0
2022	0	—	0	2
2023	0	—	4	1
2024	0	—	12	1
2025	0	—	0	1
2026	0	—	0	—

https://510kreport.com/device/K930265 · printed Nov 3, 2026

Cite this page

510(k) Report. “K930265: Hydrogen Spectroscopy Option-Probe #M1040HS/HT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K930265

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026