510(k) · Cleared

Cleared

Artoscan M

K963262510(k) TraditionalCleared Mar 28, 1997220-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

Biosound, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 28, 1997 as substantially equivalent to K931022 (Biosound, Inc., 1993) and 9 other predicates after a 220-day review. Its family tree reaches back 1 generation to 1991. 51 later devices descend from it.

Decided: Mar 28, 1997
Review: 220 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 10

Its longest line of descent runs back 1 generation to K911667 (1991). 10 ancestors in all. 51 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK911667 Hitachi MRP-7000 Magnetic Rosonance DeviceHitachi Medical Systems America, Inc. · 1991 · Recalled
This deviceK963262 Artoscan MBiosound, Inc. · 1997
Descendant · cites it directly · 50 of its ownK981358 Artoscan SBiosound Esaote, Inc. · 1998
Descendant · 2 generations on · 49 of its ownK990968 E-SCANBiosound Esaote, Inc. · 1999
Descendant · cites it directly · 48 of its ownK020164 E-Scan XQBiosound Esaote, Inc. · 2002
Descendant · cites it directly · 47 of its ownK032121 Modification to E-Scan XQEsaote, S.p.A. · 2003
Descendant · 2 generations on · 45 of its ownK042236 G-SCANEsaote, S.p.A. · 2004

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

1998high 7 (2012) · low 0 (2000)2026

Most influential descendants

Showing 5 of 51 · See all

K981358Artoscan SBiosound Esaote, Inc. · 1998 · cites it directly50descendants
K990968E-SCANBiosound Esaote, Inc. · 1999 · 2 generations on49descendants
K020164E-Scan XQBiosound Esaote, Inc. · 2002 · cites it directly48descendants
K032121Modification to E-Scan XQEsaote, S.p.A. · 2003 · cites it directly47descendants
K042236G-SCANEsaote, S.p.A. · 2004 · 2 generations on45descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911667	Hitachi MRP-7000 Magnetic Rosonance Device	Hitachi Medical Systems America, Inc.	1991	2
0 (this device)	K963262	Artoscan M	Biosound, Inc.	1997	—
+1	K981358	Artoscan S	Biosound Esaote, Inc.	1998	—
+2	K990968	E-SCAN	Biosound Esaote, Inc.	1999	—
+1	K020164	E-Scan XQ	Biosound Esaote, Inc.	2002	—
+1	K032121	Modification to E-Scan XQ	Esaote, S.p.A.	2003	—
+2	K042236	G-SCAN	Esaote, S.p.A.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1992	2	0
1993	3	0
1994	3	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2006	3	0
2008	4	0
2009	2	0
2010	2	0
2011	4	0
2012	7	0
2013	3	0
2015	4	0
2016	3	0
2017	1	0
2019	4	0
2021	1	0
2022	1	0
2024	2	0
2026	3	0

FIG. 1 — Lineage of K963262, 1991–2026Source: 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? (10)

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
*	K931022	Artoscan Summary page 2 …Imaging Device Classification Name(s): System, Nuclear Magnetic Resonance Imaging Classification Number: A 892.1000 807.92(a)(3) Predicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K91…	Biosound, Inc.	1993	—
*	K931008	Model #QWH-63, Quadrature Wrist and Hand Coil Summary page 2 …cation Name(s): System, Nuclear Magnetic Resonance Imaging Classification Number: A 892.1000 807.92(a)(3) Predicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K…	Mri Devices Corp.	1993	—
*	K911667	Hitachi MRP-7000 Magnetic Rosonance Device Summary page 2 …lear Magnetic Resonance Imaging Classification Number: A 892.1000 807.92(a)(3) Predicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MR…	Hitachi Medical Systems America, Inc.	1991	2
*	K934396	Quadrature Lower Extremity Coil Summary page 2 …Classification Number: A 892.1000 807.92(a)(3) Predicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 H…	Medical Advances, Inc.	1993	—
*	K935661	Magnetom Open Summary page 2 …892.1000 807.92(a)(3) Predicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 Hitachi Mobile NW 7000 K9201…	Siemens Medical Solutions USA, Inc.	1994	—
*	K911642	MRP-5000 and MRP-7000 Multiplanar Reconstruction Summary page 2 …edicate Device(s) o Esaote ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 Hitachi Mobile NW 7000 K920159 Additional Substanti…	Hitachi Medical Systems America, Inc.	1991	—
*	K940534	Gyroscan T10-NT (Release 4 Series Software) Summary page 2 …ARTOSCAN K931022 MRI Device Corp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 Hitachi Mobile NW 7000 K920159 Additional Substantial Equivalence information…	Philips Medical Systems, Inc.	1994	1
*	K924154	Kinematic Mri Moviemaker Summary page 2 …rp. K931008 ¢ Hitachi MRP-7000 K911667 Medical Advances, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 Hitachi Mobile NW 7000 K920159 Additional Substantial Equivalence information is provided in the attached Su…	Resonex, Inc.	1992	—
*	K940894	Magna SL Our OCR of the scanned summary read K940849, which is not a number in FDA’s lists. Corrected to the only number with two digits swapped in this product code whose FDA name shares the summary’s words.	Magna-Lab, Inc.	1994	—
*	K920159	Mobile MRP-7000 Summary page 2 …nces, Inc. K934396 ¢ Siemans Magnetom K935661 Hitachi NW 5000 K911642 ¢ Philips Gyroscan K940534 Resonex Kinematic MRl K924154 e Magna Lab K940849 Hitachi Mobile NW 7000 K920159 Additional Substantial Equivalence information is provided in the attached Substantial Equivalence Comparison Table. 807.92(a)(…	Hitachi Medical Systems America, Inc.	1992	—
†	K950837	Aurora Imaging System	Advanced Mammography Systems, Inc.	1996	—

What descends from it? (51)

See all 51

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

Number	Device	Applicant	Decided	Descendants
K981358	Artoscan S	Biosound Esaote, Inc.	1998	50
K020164	E-Scan XQ	Biosound Esaote, Inc.	2002	48
K032121	Modification to E-Scan XQ	Esaote, S.p.A.	2003	47

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?

2 of the 10 ancestors have a recall of any class.
Of its descendants, K981358 (Biosound Esaote, Inc., 1998) has gone furthest, with 50 descendants of its own.

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 ARTOSCAN M is intended for diagnostic nuclear magnetic imaging of the knee, leg, ankle,

foot, hand, wrist forearm and elbow. The device produces transverse, sagittal, coronal and

oblique cross-sectional images displaying the internal structure of the anatomy being imaged.

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/K963262 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963262: Artoscan M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963262

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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