510(k) · Cleared

Cleared

Movable Add-on Couch for Outlook

K960973510(k) TraditionalCleared May 29, 199679-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 May 29, 1996 as substantially equivalent to K945827 (Philips Medical Systems (Cleveland), Inc., 1995) after a 79-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: May 29, 1996
Review: 79 days
Class: Class II
Product code: LNH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945827 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945827 OutlookPhilips Medical Systems (Cleveland), Inc. · 1995
This deviceK960973 Movable Add-on Couch for OutlookPhilips Medical Systems (Cleveland), Inc. · 1996
Descendant · cites it directly · 0 of its ownK992892 Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999

Most influential descendants

Showing 1 of 1 · See all

K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945827	Outlook	Philips Medical Systems (Cleveland), Inc.	1995	—
0 (this device)	K960973	Movable Add-on Couch for Outlook	Philips Medical Systems (Cleveland), Inc.	1996	—
+1	K992892	Stepping Kinematic Imaging Platform (Skip)	Magnetic Moments, LLC	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K960973, 1995–1999Source: 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
*	K945827	Outlook Summary page 2 …TLOOK Length 2400 mm 2400 mm Width of couch plate 625 mm (+ handle 55mm) 625 mm Height to the edge of the \| 880 mm (upper 880 mm couch position) (Outlook standard couch K945827) Portable yes no (Outlook standard couch K945827) PICKER INTERNATIONAL, INC. (MCO) (3/7/96) I-2 PARAMETER MOV…	Philips Medical Systems (Cleveland), Inc.	1995	—
†	K944973	NRF System	Philips Medical Systems (Cleveland), Inc.	1994	—

Also cleared against K945827: 7 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
K992892	Stepping Kinematic Imaging Platform (Skip)	Magnetic Moments, LLC	1999	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?

Its one ancestor has no recall.
Of its descendants, K992892 (Magnetic Moments, LLC, 1999) has gone furthest, with 0 descendants of its own.
7 other devices also cite its predicate K945827.

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 Movable Add-on Couch is designed to be used with the Outlook MRI system

and in an X-Ray environment. The indications for use are the same as for standard

MR imaging.

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/K960973 · printed Nov 5, 2026

Cite this page

510(k) Report. “K960973: Movable Add-on Couch for Outlook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960973

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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