510(k) · Cleared

Cleared

31P/1H Headcoil for Magnetom Allegra

K042617510(k) TraditionalCleared Nov 5, 200442-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

Siemens Medical Solutions USA, Inc. · MOS Coil, Magnetic Resonance, Specialty

Cleared on Nov 5, 2004 as substantially equivalent to K962627 (Siemens Medical Solutions USA, Inc., 1997) after a 42-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Nov 5, 2004
Review: 42 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962627 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962627 Clinical Phosphorus Spectroscopy Option/Magnetom Vision SystemSiemens Medical Solutions USA, Inc. · 1997
This deviceK042617 31P/1H Headcoil for Magnetom AllegraSiemens Medical Solutions USA, Inc. · 2004
Descendant · cites it directly · 0 of its ownK080820 Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K080820Tem 3002G- HN Dual Tune Head CoilMr Instruments, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962627	Clinical Phosphorus Spectroscopy Option/Magnetom Vision System	Siemens Medical Solutions USA, Inc.	1997	—
0 (this device)	K042617	31P/1H Headcoil for Magnetom Allegra	Siemens Medical Solutions USA, Inc.	2004	—
+1	K080820	Tem 3002G- HN Dual Tune Head Coil	Mr Instruments, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K042617, 1997–2008Source: 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 MOS? 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 MOS device

#1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 generations · no Class I recall
#2 Held for the reportin the report
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What was it cleared against? (3)

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
*	K962627	Clinical Phosphorus Spectroscopy Option/Magnetom Vision System Summary page 2 …Premarket Notification Clearance Date Siemens Medical Solutions 31P/IH heart/liver coil for Clinical Phosphorus K962627 March 04, 1997 Spectroscopy Option MAGNETOM Vision Siemens Medical Solutions 31P/IH heart/liv…	Siemens Medical Solutions USA, Inc.	1997	—
*	—	31P/1H heart/liver coil included in syngo MR 2002B Named without a submission number			—
*	—	Signa 1.5T Phosphorus Transmit/Receive Flex Coil Named without a submission number			—

Also cleared against K962627: 1 other device →

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
K080820	Tem 3002G- HN Dual Tune Head Coil	Mr Instruments, Inc.	2008	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?

Its one ancestor has no recall.
Of its descendants, K080820 (Mr Instruments, Inc., 2008) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K962627.

How does its category compare?

All MOS devices

MOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MOS

3in 2025

2007high 25 (2011) · low 3 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MOS

59in 2025

2007high 178 (2019) · low 19 (2007)2026

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

Recalls per year · MOS

13in 2024

2007high 13 (2024) · low 0 (2007)2026

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

Adverse event reports per year · MOS

2in 2025

2007high 13 (2010) · low 2 (2008)2025

MAUDE reports naming product code MOS, 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	16	19	0	4
2008	19	33	2	2
2009	10	43	0	5
2010	16	78	1	13
2011	25	57	0	7
2012	15	49	1	12
2013	7	87	0	10
2014	12	60	0	4
2015	6	58	2	5
2016	11	42	0	7
2017	9	63	0	9
2018	10	30	0	7
2019	3	178	8	8
2020	5	51	1	2
2021	4	41	0	3
2022	11	79	0	5
2023	10	59	0	4
2024	10	39	13	8
2025	3	59	0	2
2026	10	45	0	—

What is it indicated for?

The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31 P) and proton (I H) frequencies. Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique I H images and 1H spectra of the internal structures of the head. In addition, 31 P spectra can be obtained within the same session without changing the coil. The images…

Read the full statement (145 words)

The 31P/1H headcoil for MAGNETOM Allegra is a transmit/receive birdcage type headcoil double resonant on phosphorus (31 P) and proton (I H) frequencies.

Used in the Allegra system it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique I H images and 1H spectra of the internal structures of the head. In addition, 31 P spectra can be obtained within the same session without changing the coil.

The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules, in which the nucleus under investigation is contained, to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (Tl), spin-spin echo time (T2) of the corresponding nucleus.

When interpreted by a trained physician, these images and spectra provide information that can be useful in determining diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K042617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042617: 31P/1H Headcoil for Magnetom Allegra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042617

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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