510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Gyroscan Acs-NT, Gyroscan T5-NT and Gyroscan T10-NT

K945945510(k) TraditionalCleared Dec 22, 1995382-day reviewClass II21 CFR 892.1000Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems North America, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Dec 22, 1995 after a 382-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 5 times.

Decided
Dec 22, 1995
Review
382 days
Class
Class II
Product code
LNH
Recalls
5
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K945945Source: FDA 510(k) database · How lineage is built

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

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 16, 2018Class IIZ-1439-2018Nonconforming Material/ComponentPotential risk for helium gas inside the MR examination room during a magnet quench
Mar 16, 2018Class IIZ-1438-2018Nonconforming Material/ComponentPotential risk for helium gas inside the MR examination room during a magnet quench
Mar 16, 2018Class IIZ-1440-2018Nonconforming Material/ComponentPotential risk for helium gas inside the MR examination room during a magnet quench
Jul 6, 2015Class IIZ-1024-2016Device DesignWrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables…
Apr 30, 2007Not classifiedZ-0981-2007OtherPotential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

No ancestor or descendant has a Class I 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

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—

More from Philips Medical Systems North America…

71 FDA decisions under this applicant name. See the company

  • K102005Allura Xper or Table SeriesPhilips Medical Systems North America, Inc. · 201039 recalls
  • K062233Heartstart MRX Monitor/DefibrillatorPhilips Medical Systems North America, Inc. · 20062 Class I recalls
  • K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006
  • K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006
  • K050151Multidiagnost ElevaPhilips Medical Systems North America, Inc. · 200521 recalls

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The LNH category page

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https://510kreport.com/device/K945945 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945945: Gyroscan Acs-NT, Gyroscan T5-NT and Gyroscan T10-NT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945945

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026