510(k) · Cleared

Cleared

Kinematic Positioning Devices; C-Spine, Knee,Shoulder

K964752510(k) TraditionalCleared Feb 24, 199789-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

Philips Medical Systems (Cleveland), Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 24, 1997 as substantially equivalent to K961121 (Siemens Medical Solutions USA, Inc., 1996) after an 89-day review. Its family tree reaches back 2 generations to 1992.

Decided: Feb 24, 1997
Review: 89 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K924154 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK924154 Kinematic Mri MoviemakerResonex, Inc. · 1992
1 generation backK961121 Kinematic Knee Device/Magnetom Open SystemSiemens Medical Solutions USA, Inc. · 1996
This deviceK964752 Kinematic Positioning Devices; C-Spine, Knee,ShoulderPhilips Medical Systems (Cleveland), Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K924154	Kinematic Mri Moviemaker	Resonex, Inc.	1992	—
−1	K961121	Kinematic Knee Device/Magnetom Open System	Siemens Medical Solutions USA, Inc.	1996	—
0 (this device)	K964752	Kinematic Positioning Devices; C-Spine, Knee,Shoulder	Philips Medical Systems (Cleveland), Inc.	1997	—

FIG. 1 — Lineage of K964752, 1992–1997Source: 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? (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
*	K961121	Kinematic Knee Device/Magnetom Open System Summary page 2 …tic Positioning Devices for the Outlook are similar in technological characteristics and intended use to the Siemen’s Kinematic Knee Device for the Magnetom Open System (K961121). The following chart has been created to demonstrate their substantial equivalence. PICKER INTERNATIONAL, INC. (KINE) 2/19/97 I…	Siemens Medical Solutions USA, Inc.	1996	—

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?

The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
None of the 2 ancestors has a recall.

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 Picker International Outlook system is intended for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the…

Read the full statement (116 words)

The Picker International Outlook system is intended for use as a NMR device that

produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2)

depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time

T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and

whole body. When interpreted by a trained physician, these images yield information that

can be useful in the determination of a diagnosis.

The Kinematic Positioning Devices enable the physician to evaluate the anatomy and the

functional interactions of the surrounding tissues (ligaments, cartilage, bone, muscle and

fat). The Kinematic Positioning Devices are indicated for use in the Cervical Spine, Knee

and Shoulder.

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/K964752 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964752: Kinematic Positioning Devices; C-Spine, Knee,Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964752

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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