510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Intera Family

K030520510(k) TraditionalCleared Mar 6, 200315-day reviewClass II21 CFR 892.1000Recalls 12

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 Co. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Mar 6, 2003 after a 15-day review. The FDA summary names its predicate without a number. It has been recalled 12 times.

Decided
Mar 6, 2003
Review
15 days
Class
Class II
Product code
LNH
Recalls
12
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K030520Source: 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), 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—Gyroscan / NT INTERA family
Named without a submission number
—

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
Aug 21, 2026Class IIZ-3240-2026Software designA software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.
Dec 21, 2018Class IIZ-0881-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0879-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0877-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0878-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0880-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0874-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0883-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Dec 21, 2018Class IIZ-0886-2019Unknown/Undetermined by firmThere is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
Mar 16, 2018Class IIZ-1431-2018Nonconforming Material/ComponentPotential risk for helium gas inside the MR examination room during a magnet quench
Mar 16, 2018Class IIZ-1432-2018Nonconforming 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…

The 5 latest of 12 recalls; the web page lists all.

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—

What is it indicated for?

The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis.

Indications for use as stated in the FDA summary.

More from Philips Medical Systems North America…

24 FDA decisions under this applicant name. See the company

  • K101311EP Navigator R3Philips Medical Systems North America Co. · 2010
  • K090625Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 200928 recalls
  • K090590Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
  • K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs MonitorPhilips Medical Systems North America Co. · 2008
  • K063781Philips XD-S Direct Radiography Workstation/PackagePhilips Medical Systems North America Co. · 20071 recall

Recent decisions in LNH

The LNH category page

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https://510kreport.com/device/K030520 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030520: Intera Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030520

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026