510(k) Report

510(k) · Cleared

Cleared

Stepping Kinematic Imaging Platform (Skip)

K992892510(k) TraditionalCleared Sep 16, 199920-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

Magnetic Moments, LLC · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Sep 16, 1999 as substantially equivalent to K980645 (Philips Medical Systems North America, Inc., 1998) and 4 other predicates after a 20-day review. Its family tree reaches back 2 generations to 1995.

Decided
Sep 16, 1999
Review
20 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K945827 (1995). 7 ancestors in all, the oldest K931544 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1997: 1 other ancestorK945827 · Outlook · Philips Medical Systems (Cleveland), Inc. · 1995K960973 · Movable Add-on Couch for Outlook · Philips Medical Systems (Cleveland), Inc. · 1996199019921994199619982000
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor K960973 · Movable Add-on Couch for Outlook · Philips Medical Systems (Cleveland), Inc. · 1996K945827 · Outlook · Philips Medical Systems (Cleveland), Inc. · 19950
  1. Root · 2 generations backK945827 OutlookPhilips Medical Systems (Cleveland), Inc. · 1995
  2. 1 generation backK960973 Movable Add-on Couch for OutlookPhilips Medical Systems (Cleveland), Inc. · 1996
  3. This deviceK992892 Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K945827OutlookPhilips Medical Systems (Cleveland), Inc.1995—
−1K960973Movable Add-on Couch for OutlookPhilips Medical Systems (Cleveland), Inc.1996—
0 (this device)K992892Stepping Kinematic Imaging Platform (Skip)Magnetic Moments, LLC1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
199510
199710
199810
FIG. 1 — Lineage of K992892, 1995–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K980645Philips Gyroscan NT Release 6 Series
Summary page 1
…Shetty, Ph.D Name of the Device: Stepping Kinematic Imaging Platform (SKIP™) Predicate Device Information: a. Philips Gyroscan NT Platform with MobiTrak™ Package, K# 980645, Philips Medical Systems, NA, Shelton, CT b. Siemens Magnetom Vision, K# 940541, Siemens, CA c. General Electric Signa Horizon…
Philips Medical Systems North America, Inc.1998—
*K940541Magnetic Resonance Diag Device Magnetom Vision (Modif)
Summary page 1
…redicate Device Information: a. Philips Gyroscan NT Platform with MobiTrak™ Package, K# 980645, Philips Medical Systems, NA, Shelton, CT b. Siemens Magnetom Vision, K# 940541, Siemens, CA c. General Electric Signa Horizon LX, K# 942604, General Electric Medical Systems d. Picker Eclipse VISTA, K# 9315…
Siemens Medical Solutions USA, Inc.1994—
*K942604Signa Advantage SP Magnetic Resonance System
Summary page 1
…with MobiTrak™ Package, K# 980645, Philips Medical Systems, NA, Shelton, CT b. Siemens Magnetom Vision, K# 940541, Siemens, CA c. General Electric Signa Horizon LX, K# 942604, General Electric Medical Systems d. Picker Eclipse VISTA, K# 931544, Picker International, Inc. Device Description: The “SKIP…
GE Medical Systems19951
*K9315441.5T Edge and 1.0T Vista Systems
Summary page 1
…n, CT b. Siemens Magnetom Vision, K# 940541, Siemens, CA c. General Electric Signa Horizon LX, K# 942604, General Electric Medical Systems d. Picker Eclipse VISTA, K# 931544, Picker International, Inc. Device Description: The “SKIP™" table consists of three major components: two platforms consisting…
Philips Medical Systems (Cleveland), Inc.19932
*K960973Movable Add-on Couch for Outlook
Summary page 2
…“SKIP™" device is substantially equivalent to previously cleared 510(k)’s with MRI tables, and, particularly, the Philips Gyroscan NT Platform with MobiTrak™ Package, K# 960973. The MobiTrak™ Package accessory to the Gyroscan NT MR Scanner (Philips) is capable of rapid translation of patient to center di…
Philips Medical Systems (Cleveland), Inc.1996—

Also cleared against K980645: 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?

  • The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
  • 2 of the 7 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K980645.

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

2007: 122008: 192009: 172010: 122011: 162012: 222013: 192014: 172015: 192016: 202017: 182018: 292019: 262020: 322021: 272022: 302023: 302024: 262025: 262026 (partial year): 24
2007high 32 (2020) · low 12 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LNH

122in 2025

2007: 35 days median2008: 53 days median2009: 70 days median2010: 94 days median2011: 81 days median2012: 89 days median2013: 108 days median2014: 108 days median2015: 140 days median2016: 108 days median2017: 98 days median2018: 128 days median2019: 62 days median2020: 121 days median2021: 87 days median2022: 74 days median2023: 124 days median2024: 104 days median2025: 122 days median2026 (partial year): 126 days median
2007high 140 (2015) · low 35 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LNH

8in 2025

2007: 252008: 122009: 72010: 172011: 112012: 52013: 22014: 132015: 12, 2 Class I2016: 12018: 712019: 52020: 42021: 412022: 132023: 10, 1 Class I2024: 42025: 8, 5 Class I2026 (partial year): 43
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

2007: 1142008: 1672009: 1942010: 1652011: 1822012: 1702013: 1072014: 1192015: 1132016: 1352017: 1212018: 1582019: 1582020: 982021: 842022: 1382023: 1592024: 2812025: 1,263
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007123525114
2008195312167
200917707194
2010129417165
2011168111182
201222895170
2013191082107
20141710813119
20151914012 (2)113
2016201081135
201718980121
20182912871158
201926625158
202032121498
202127874184
2022307413138
20233012410 (1)159
2024261044281
2025261228 (5)1,263
20262412643—

What is it indicated for?

The device is intended to translate (reposition) the patient manually within a magnetic resonance imaging machine, through the magnet bore, in order to center different regions-of-interest at the center of the magnetic field for either multistation MRA with single dose injection or multistation MRI, using existing system hardware, software and imaging coils.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K980645

3 other devices cite the same predicate.

  • K992533Philips Gyroscan Intera (*)Philips Medical Systems North America, Inc. · 1999
  • K991765Synergy Shoulder CoilPhilips Medical Systems North America, Inc. · 1999
  • K982834Restgrid Package/Gyroscan NTPhilips Medical Systems North America, Inc. · 1998

Recent decisions in LNH

The LNH category page

  • K262902ECHELON SynergyFujifilm Corporation · 2026
  • K260092Vista AI ScanVista AI, Inc. · 2026
  • K261612SwiftSight-BodyCompositionAirs Medical, Inc. · 2026
  • K261283APERTO Lucent MRI SystemFujifilm Corporation · 2026
  • K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd. · 2026

https://510kreport.com/device/K992892 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992892: Stepping Kinematic Imaging Platform (Skip).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992892

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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