510(k) · Cleared

Cleared

Numaris 4VA15A

K012202510(k) TraditionalCleared Sep 27, 200176-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 Corp. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Sep 27, 2001 as substantially equivalent to K993731 (Siemens Medical Solutions USA, Inc., 1999) and 3 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1997.

Decided: Sep 27, 2001
Review: 76 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K970852 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK970852 Magnetom Project 024 System (Numaris 3.5 Software)Siemens Medical Solutions USA, Inc. · 1997 · Recalled
This deviceK012202 Numaris 4VA15ASiemens Medical Corp. · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K970852	Magnetom Project 024 System (Numaris 3.5 Software)	Siemens Medical Solutions USA, Inc.	1997	8
0 (this device)	K012202	Numaris 4VA15A	Siemens Medical Corp.	2001	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1999	1	0
2000	1	0

FIG. 1 — Lineage of K012202, 1997–2001Source: 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? (5)

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
*	K993731	Sonata Gradients/Magnetom Symphony System Summary page 2 …GNETOM Systems with Numaris 4VA12A. The MAGNETOM Systems which will be affected will be: e The MAGNETOM 1.5 Tesla Sonata system was described in premarket notification K993731 that received FDA clearance on December 23, 1999. e The MAGNETOM 1.5 Tesla Symphony systern was described in premarket notificat…	Siemens Medical Solutions USA, Inc.	1999	4
*	K971684	Magnetom Project 047 System (Numaris 3.5 Software) Summary page 2 …ed in premarket notification K993731 that received FDA clearance on December 23, 1999. e The MAGNETOM 1.5 Tesla Symphony systern was described in premarket notification K971684 which received FDA clearance on August 4, 1997. e The MAGNETOM 1.0 Tesla Harmony system was described in premarket notification…	Siemens Medical Solutions USA, Inc.	1997	4
*	K970852	Magnetom Project 024 System (Numaris 3.5 Software) Summary page 2 …cribed in premarket notification K971684 which received FDA clearance on August 4, 1997. e The MAGNETOM 1.0 Tesla Harmony system was described in premarket notification K970852 which received FDA clearance on June 5, 1997. e The MAGNETOM 0.2 Tesla Concerto system was described in premarket notification K…	Siemens Medical Solutions USA, Inc.	1997	8
*	K003192	Magnetic Concerto Summary page 2 …scribed in premarket notification K970852 which received FDA clearance on June 5, 1997. e The MAGNETOM 0.2 Tesla Concerto system was described in premarket notification K003192 which received FDA clearance on 12/21/00. This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and O…	Siemens Medical Solutions USA, Inc.	2000	—
*	—	MAGNETOM Systems with Numaris 4VA12A Named without a submission number			—

Also cleared against K993731: 3 other devices →

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?

3 of the 4 ancestors have a recall of any class.
3 other devices also cite its predicate K993731.

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 MAGNETOM Systems with the Numaris 4 VA15A are indicated for use as magnetic resonance diagnostic devices (MRDD’s) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, based upon 'H and *'P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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/K012202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012202: Numaris 4VA15A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012202

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026