510(k) · Cleared

Cleared

Supervan 1.5T Magnetic Resonance Imaging System

K131896510(k) TraditionalCleared Feb 28, 2014248-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

Suzhou Anke Medical System Co., Ltd. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 28, 2014 as substantially equivalent to K052013 (Philips Medical Systems Nederland B.V., 2005) after a 248-day review. Its family tree reaches back 3 generations to 2003. 2 of the 4 devices in its family, counting itself, have a Class I recall.

Decided: Feb 28, 2014
Review: 248 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K031815 (2003). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK031815 Intera-Sensation FamilyPhilips Medical Systems · 2003 · Recalled
2 generations backK043147 Achieva FamilyPhilips Medical Systems North America Co. · 2005 · Recalled (Class I)
1 generation backK052013 Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005 · Recalled (Class I)
This deviceK131896 Supervan 1.5T Magnetic Resonance Imaging SystemSuzhou Anke Medical System Co., Ltd. · 2014

Class I recalls in this family

K052013 Achieva 1.5T & Inera 1.5T Familydirect predicate · 2005
K043147 Achieva Family2 generations back · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K031815	Intera-Sensation Family	Philips Medical Systems	2003	3
−2	K043147	Achieva Family	Philips Medical Systems North America Co.	2005	Class I
−1	K052013	Achieva 1.5T & Inera 1.5T Family	Philips Medical Systems Nederland B.V.	2005	Class I
0 (this device)	K131896	Supervan 1.5T Magnetic Resonance Imaging System	Suzhou Anke Medical System Co., Ltd.	2014	—

FIG. 1 — Lineage of K131896, 2003–2014Source: 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.

2 devices in this family have a Class I recall. 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? (1)

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
*	K052013	Achieva 1.5T & Inera 1.5T Family Summary page 2 …. These images when interpreted by a trained physician, yield information that may assist in diagnosis. 5. Predicate Device Identification 510(k) Number: K052013 Product Name: ACI tWFA 1.5-F & INThRA 1.5' famnily Manufacturer: Philips Medical Systems Nederland 13V 6.…	Philips Medical Systems Nederland B.V.	2005	Class I

Also cleared against K052013: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K052013Achieva 1.5T & Inera 1.5T FamilyPhilips Medical Systems Nederland B.V. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
K043147Achieva FamilyPhilips Medical Systems North America Co. · 2005 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls

What does this lineage say?

The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
3 of the 3 ancestors have a recall of any class; 2 have a Class I recall.
1 other device also cites its predicate K052013.

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. 2014, this device’s year, is highlighted.

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?

SuperVan 1.5T Magnetic Resonance Imaging System is a MRI system that produces transversal, sagittal and coronal and oblique cross-section images of the internal structure of the whole body. The images produced by the SuperVan 1.5T system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K131896 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131896: Supervan 1.5T Magnetic Resonance Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131896

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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