510(k) Report

510(k) · Cleared

Cleared

Isaac 1.5 T MR System

K020268510(k) TraditionalCleared Apr 25, 200290-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

Chi, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Apr 25, 2002 as substantially equivalent to K971684 (Siemens Medical Solutions USA, Inc., 1997) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1989.

Decided
Apr 25, 2002
Review
90 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K893619 (1989). 15 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1998: 1 other ancestor1997: 3 other ancestors1995: 3 other ancestors1993: 2 other ancestors1991: 2 other ancestorsK893619 · Vista MR 2055 HP System · Philips Medical Systems (Cleveland), Inc. · 1989K960497 · Flexible Phased Array Spine Coil · Philips Medical Systems (Cleveland), Inc. · 1996K971246 · Leo 7000 Quadrature Knee Coil · Usa Instruments, Inc. · 19971985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 7 other ancestors K971246 · Leo 7000 Quadrature Knee Coil · Usa Instruments, Inc. · 1997K960497 · Flexible Phased Array Spine Coil · Philips Medical Systems (Cleveland), Inc. · 1996K893619 · Vista MR 2055 HP System · Philips Medical Systems (Cleveland), Inc. · 19890
  1. Root · 3 generations backK893619 Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc. · 1989
  2. 2 generations backK960497 Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc. · 1996
  3. 1 generation backK971246 Leo 7000 Quadrature Knee CoilUsa Instruments, Inc. · 1997
  4. This deviceK020268 Isaac 1.5 T MR SystemChi, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K893619Vista MR 2055 HP SystemPhilips Medical Systems (Cleveland), Inc.1989—
−2K960497Flexible Phased Array Spine CoilPhilips Medical Systems (Cleveland), Inc.1996—
−1K971246Leo 7000 Quadrature Knee CoilUsa Instruments, Inc.1997—
0 (this device)K020268Isaac 1.5 T MR SystemChi, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199320
199530
199730
199810
200110
FIG. 1 — Lineage of K020268, 1989–2002Source: 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
Get a 510(k) Report

What was it cleared against? (7)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K971684Magnetom Project 047 System (Numaris 3.5 Software)
Summary page 1
…valent to the Siemens Magnetom Symphony The applicant believes that the device now called the Symphony is the same as the Siemens Magnetom Project 047, cleared by FDA as K971684 on August 5, 1997. In regard to the six receive-only specialty coils, they are substantially equivalent to the similar coils man…
Siemens Medical Solutions USA, Inc.19974
*K971246Leo 7000 Quadrature Knee Coil
Summary page 1
…y specialty coils, they are substantially equivalent to the similar coils manufactured by USA Instruments. These were cIear}éd for marketing under the following 510(k)s: K971246 (knee coil), KO10946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil). DEVICE DESCRIP…
Usa Instruments, Inc.1997—
*K010946Mark 9000 Phased Array Shoulder CoilUsa Instruments, Inc.2001—
*K964531Profile 70000 Quadrature Volume Neck Coil
Summary page 1
…valent to the similar coils manufactured by USA Instruments. These were cIear}éd for marketing under the following 510(k)s: K971246 (knee coil), KO10946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil). DEVICE DESCRIPTION The ISAAC 1.5: T MR System is a new clin…
Us Asia Instruments, Inc.1997—
*K972205Alpha 7000 Quadrature Wrist Coil
Summary page 1
…coils manufactured by USA Instruments. These were cIear}éd for marketing under the following 510(k)s: K971246 (knee coil), KO10946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil). DEVICE DESCRIPTION The ISAAC 1.5: T MR System is a new clinical whole-body MR sy…
Usa Instruments, Inc.1997—
Kept off the family treeK982340FDA’s K982340 is Extracorporeal Blood Circuit
Our OCR of the scanned summary read K982340, FDA’s number for Extracorporeal Blood Circuit (Haidylena Medical Egypt). Its FDA name has none of the distinctive words the summary uses for the device it names, “USA Instruments specialty coil”. Kept off the family tree.
Summary page 1
…USA Instruments. These were cIear}éd for marketing under the following 510(k)s: K971246 (knee coil), KO10946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil). DEVICE DESCRIPTION The ISAAC 1.5: T MR System is a new clinical whole-body MR system, utilizing 'a sup…
Haidylena Medical Egypt1999—
*K980157Premier 7000 CTL Spine Coil
Summary page 1
…nts. These were cIear}éd for marketing under the following 510(k)s: K971246 (knee coil), KO10946 (shoulder coil), K964531 (neck coil), K972205 (wrist coil), K982340, and K980157 (CTL coil). DEVICE DESCRIPTION The ISAAC 1.5: T MR System is a new clinical whole-body MR system, utilizing 'a superconducting…
Usa Instruments, Inc.1998—

Also cleared against K971684: 8 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 13 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
  • 1 of the 15 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K971684.

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 ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.

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 K971684

8 other devices cite the same predicate.

  • K071925Magnetom EssenzaSiemens Medical Solutions USA, Inc. · 20071 recall
  • K063373Flex Loop Coil Set 3TSiemens AG · 2006
  • K052423Magnetom Systems with Syngo Expert - I OptionSiemens Medi Cal Solutions, Inc. · 2006
  • K050199Magnetom Symphony a Tim SystemSiemens Medical Solution · 2005
  • K032428Magnetom Avanto MR SystemSiemens Medical Solutions USA, Inc. · 20034 recalls
  • K020991Syngo MR 2002BSiemens Medical Solutions USA, Inc. · 20022 recalls

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/K020268 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020268: Isaac 1.5 T MR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020268

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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