510(k) Report

510(k) · Cleared

Cleared

Ies, Image Enhancement System

K922470510(k) TraditionalCleared Nov 27, 1992185-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

Open Mri, Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Nov 27, 1992 after a 185-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 121 later devices descend from it.

Decided
Nov 27, 1992
Review
185 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
0

121 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2006: 1 descendant cleared2003: 1 descendant cleared2005: 2 descendants cleared2018: 9 descendants cleared2014: 4 descendants cleared2007: 2 descendants cleared2010: 1 descendant cleared2016: 4 descendants cleared2008: 4 descendants cleared2021: 13 descendants cleared2009: 3 descendants cleared2019: 6 descendants cleared2013: 1 descendant cleared2022: 7 descendants cleared2026: 16 descendants cleared2017: 6 descendants cleared2024: 12 descendants cleared2023: 10 descendants cleared2025: 11 descendants cleared2015: 1 descendant cleared2020: 6 descendants cleared1990200020102020
  1. This deviceK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
  2. Descendant · cites it directly · 120 of its ownK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
  3. Descendant · 2 generations on · 106 of its ownK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
  4. Descendant · 3 generations on · 64 of its ownK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
  5. Descendant · 4 generations on · 53 of its ownK080555 Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008
  6. Descendant · 5 generations on · 50 of its ownK123209 SoftvueDelphinus Medical Technologies, Inc. · 2013

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2000: 12003: 12005: 22006: 12007: 22008: 42009: 32010: 12013: 12014: 42015: 12016: 42017: 62018: 92019: 62020: 62021: 132022: 72023: 102024: 122025: 112026: 16
2000high 16 (2026) · low 0 (2001)2026

Most influential descendants

Showing 5 of 121 · See all
  • K993802Sharpview Image Enhancement SystemContext Vision AB · 2000 · cites it directly120descendants
  • K024028Sharp View Image Enhancement SystemContext Vision AB · 2003 · 2 generations on106descendants
  • K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005 · 3 generations on64descendants
  • K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation · 2008 · 4 generations on53descendants
  • K123209SoftvueDelphinus Medical Technologies, Inc. · 2013 · 5 generations on50descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K922470Ies, Image Enhancement SystemOpen Mri, Inc.1992—
+1K993802Sharpview Image Enhancement SystemContext Vision AB2000—
+2K024028Sharp View Image Enhancement SystemContext Vision AB2003—
+3K052355Automated Breast Ultrasound System, Model AbusU-Systems, Inc.2005—
+4K080555Sofia Automated Tomographic Ultrasound (Atus)Ivu Imaging Corporation2008—
+5K123209SoftvueDelphinus Medical Technologies, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200520
200610
200720
200840
200930
201010
201310
201440
201510
201640
201760
201890
201960
202060
2021130
202270
2023100
2024120
2025110
2026160
FIG. 1 — Lineage of K922470, 1992–2026Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K993802Sharpview Image Enhancement SystemContext Vision AB2000120

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?

  • Of its descendants, K993802 (Context Vision AB, 2000) has gone furthest, with 120 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—

More from Open Mri, Inc.

2 FDA decisions under this applicant name. See the company

  • K950431Lossless Teleradiology Option for Use with Ies, Image Enhancement SystemOpen Mri, Inc. · 1995

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https://510kreport.com/device/K922470 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922470: Ies, Image Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922470

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