510(k) · Cleared

Cleared

Noras CPC Multifunctional Coil

K083578510(k) AbbreviatedCleared Jan 16, 200944-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

Noras Mri Products GmbH · MOS Coil, Magnetic Resonance, Specialty

Cleared on Jan 16, 2009 as substantially equivalent to K012491 (Machnet BV, 2001) and 5 other predicates after a 44-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it.

Decided: Jan 16, 2009
Review: 44 days
Class: Class II
Product code: MOS
Recalls: None
Predicates: 6

Its longest line of descent runs back 4 generations to K971684 (1997). 15 ancestors in all, the oldest K945778 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK971684 Magnetom Project 047 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
3 generations backK032428 Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 2003 · Recalled
2 generations backK050200 Magnetom Trio a Tim SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
1 generation backK063373 Flex Loop Coil Set 3TSiemens AG · 2006
This deviceK083578 Noras CPC Multifunctional CoilNoras Mri Products GmbH · 2009
Descendant · cites it directly · 0 of its ownK140252 16 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014

Most influential descendants

Showing 1 of 1 · See all

K14025216 CH Multipurpose Coil VarietyNoras Rontgen-Und Medizintechnik GmbH · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K971684	Magnetom Project 047 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	4
−3	K032428	Magnetom Avanto MR System	Siemens Medical Solutions USA, Inc.	2003	4
−2	K050200	Magnetom Trio a Tim System	Siemens Medical Solutions USA, Inc.	2005	3
−1	K063373	Flex Loop Coil Set 3T	Siemens AG	2006	—
0 (this device)	K083578	Noras CPC Multifunctional Coil	Noras Mri Products GmbH	2009	—
+1	K140252	16 CH Multipurpose Coil Variety	Noras Rontgen-Und Medizintechnik GmbH	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1999	2	0
2000	1	0
2001	3	0
2002	2	0
2007	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K083578, 1997–2014Source: 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
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (6)

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
*	K012491	Machnet Carotids Coil Array Assembly Summary page 3 …ntially equivalent to the following coils. Coil Name Premarket Notification Clearance Date Machnet Carotids Coil K 012491 October 24, 2001 Array Assembly Siemens Flex Loop K 063313 November 17, 200…	Machnet BV	2001	—
*	K063373	Flex Loop Coil Set 3T Our reading of the summary gave K063313, FDA’s number for Filterwire EZ Embolic Protection System (3.5 MM to 5.5 MM) (Boston Scientific Corp). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Flex Loop Coil Set 3T”.	Siemens AG	2006	—
*	K993477	HRW Wrist Array Coil Summary page 3 …er 24, 2001 Array Assembly Siemens Flex Loop K 063313 November 17, 2006 Cod Set 3T Invivo Precision Eight K 993477 January 11, 1999 Wrist Array Coil 1 5T Phased Array Shoulder Coil K 963356 November…	Mri Devices Corp.	1999	—
*	K963356	Phased Array Shoulder Coil Summary page 3 …2006 Cod Set 3T Invivo Precision Eight K 993477 January 11, 1999 Wrist Array Coil 1 5T Phased Array Shoulder Coil K 963356 November 22, 1996 Model 455GE, Phased Array K 010074 April 3, 1996 Wrist Coil M…	Philips Medical Systems (Cleveland), Inc.	1996	—
*	K010074	Model 455GE Phased Array Wrist Coil Summary page 3 …January 11, 1999 Wrist Array Coil 1 5T Phased Array Shoulder Coil K 963356 November 22, 1996 Model 455GE, Phased Array K 010074 April 3, 1996 Wrist Coil Model CG-WHC18-H150- K 071882 July 18, 2007 AP W…	Medical Advances, Inc.	2001	—
*	K071882	Model CG-WHC18-H150-AP - Wrist Hand Coil 1.5T 4 CH, Summary page 3 …November 22, 1996 Model 455GE, Phased Array K 010074 April 3, 1996 Wrist Coil Model CG-WHC18-H150- K 071882 July 18, 2007 AP Wrist Hand Coil 1 5T Noras 510(k) Premarket Notification November 20, 2008…	Shanghai Chenguang Medical Technologies Co, Ltd.	2007	—

Also cleared against K012491: 3 other devices →

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
K140252	16 CH Multipurpose Coil Variety	Noras Rontgen-Und Medizintechnik GmbH	2014	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?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
5 of the 15 ancestors have a recall of any class.
Of its descendants, K140252 (Noras Rontgen-Und Medizintechnik GmbH, 2014) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K012491.

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. 2009, this device’s year, is highlighted.

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 intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis The application area…

Read the full statement (121 words)

The intended use of the Noras CPC is, in conjunction with a Magnetic Resonance Scanner, Body-imaging for diagnostic with a MRI system

It is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of special regions of the human body When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis

The application area shouldn't be bigger than 20 cm because of the depth of penetration of 10 cm per coil The outcome of this is diagnostic images of toes, feet, ankle, knee, finger, hand, wrist, elbow, shoulder, carotid artery, inner ear and other parts of the body with similar structure can be taken

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083578 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083578: Noras CPC Multifunctional Coil.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083578

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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