510(k) Report

510(k) · Cleared

Cleared

Panorama Enhancements

K024042510(k) TraditionalCleared Feb 4, 200360-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, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Feb 4, 2003 as substantially equivalent to K013858 (Philips Medical Systems (Cleveland), Inc., 2002) and 2 other predicates after a 60-day review. Its family tree reaches back 5 generations to 1993. 4 later devices descend from it.

Decided
Feb 4, 2003
Review
60 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K931544 (1993). 8 ancestors in all. 4 later devices descend from it, 1 citing it directly.

  1. Root · 5 generations backK931544 1.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc. · 1993 · Recalled
  2. 4 generations backK954646 Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc. · 1996
  3. 3 generations backK964626 Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1997 · Recalled
  4. 2 generations backK974844 Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc. · 1998
  5. 1 generation backK013858 Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2002 · Recalled
  6. This deviceK024042 Panorama EnhancementsPhilips Medical Systems, Inc. · 2003
  7. Descendant · cites it directly · 3 of its ownK071154 Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007
  8. Descendant · 2 generations on · 0 of its ownK131737 Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014
  9. Descendant · 2 generations on · 0 of its ownK092237 NSM-S15 SystemNeusoft Medical Systems Co., Ltd. · 2009
  10. Descendant · 2 generations on · 0 of its ownK082485 Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008

Most influential descendants

Showing 4 of 4 · See all
  • K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd. · 2007 · cites it directly3descendants
  • K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd. · 2014 · 2 generations on0descendants
  • K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd. · 2009 · 2 generations on0descendants
  • K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K9315441.5T Edge and 1.0T Vista SystemsPhilips Medical Systems (Cleveland), Inc.19932
−4K954646Epi-II System Option W/High Performance GradientsPhilips Medical Systems (Cleveland), Inc.1996—
−3K964626Edge/Vista System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.19974
−2K974844Outlook System Enhancement PackagePhilips Medical Systems (Cleveland), Inc.1998—
−1K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc.20022
0 (this device)K024042Panorama EnhancementsPhilips Medical Systems, Inc.2003—
+1K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd.2007—
+2K131737Supernova C5 Mri SystemLiaoning Kampo Medical System Co., Ltd.2014—
+2K092237NSM-S15 SystemNeusoft Medical Systems Co., Ltd.2009—
+2K082485Modification to Superopen 0.23T Mri System, Model Nam-P023ANeusoft Medical Systems Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201410
FIG. 1 — Lineage of K024042, 1993–2014Source: FDA 510(k) summaries, read by 510(k) Report · 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? (3)

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
*K013858Infinion 0.6T MR Imaging SystemPhilips Medical Systems (Cleveland), Inc.20022
*K001796Gyroscan Intera (R7.5)Philips Medical Systems North America, Inc.20004
*K974844Outlook System Enhancement Package
Summary page 2
…0.6T MR KO13858 T MR Imaging - Philips Panorama 0.23 T System Imaging - Philips Intera System K974844 System family (0.5T, l.OT, - Philips Intera family (OST, l.OT,…
Philips Medical Systems (Cleveland), Inc.1998—
†K002539Obc-096 Breast Array CoilMri Devices Corp.2000—
†K981959Outlook Large Phased Array Neck CoilPhilips Medical Systems (Cleveland), Inc.1998—
†K013528Crystal 5000 Phases Array TMJ CoilUsa Instruments, Inc.2001—
†K983143Mark 5000 Phased Array Shoulder CoilUsa Instruments, Inc.1998—

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071154Superstar 0.35T Mri SystemNeusoft Medical Systems Co., Ltd.20073

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 10 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • Of its descendants, K071154 (Neusoft Medical Systems Co., Ltd., 2007) has gone furthest, with 3 descendants of its own.

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 Panorama Enhancements do not change the existing indications as defined below.

The Panorama MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and 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.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K024042: Panorama Enhancements.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024042

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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