510(k) Report

510(k) · Cleared

Cleared

Cadimas Version 1.0

K052023510(k) TraditionalCleared Dec 8, 2005135-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

Alan Penn & Associates., Inc. · LNH System, Nuclear Magnetic Resonance Imaging

Cleared on Dec 8, 2005 as substantially equivalent to K043216 (Confirma, Inc., 2005) and 2 other predicates after a 135-day review. Its family tree reaches back 6 generations to 1991.

Decided
Dec 8, 2005
Review
135 days
Class
Class II
Product code
LNH
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K913770 (1991). 19 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 2 other ancestors2004: 2 other ancestors2002: 2 other ancestors2001: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1991: 1 other ancestorK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK033400 · Seno Advantage · Ge Medical Systems W-400 · 2003 · recalledK043216 · Cadstream Version 4.0 · Confirma, Inc. · 2005K050846 · B-Cad System, Version 1.0 · The Medipattern Corporation · 20051990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 8 other ancestors3 generations back: 3 other ancestors5 generations back: 1 other ancestor K050846 · B-Cad System, Version 1.0 · The Medipattern Corporation · 2005K043216 · Cadstream Version 4.0 · Confirma, Inc. · 2005K033400 · Seno Advantage · Ge Medical Systems W-400 · 2003 · recalledK020483 · Advantage Workstation 4.1 · GE Medical Systems · 2002 · recalledK960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991−50
  1. Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
  4. 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
  5. 2 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
  6. 1 generation backK050846 B-Cad System, Version 1.0The Medipattern Corporation · 2005
  7. This deviceK052023 Cadimas Version 1.0Alan Penn & Associates., Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−5K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−4K020483Advantage Workstation 4.1GE Medical Systems20022
−3K033400Seno AdvantageGe Medical Systems W-40020036
−2K043216Cadstream Version 4.0Confirma, Inc.2005—
−1K050846B-Cad System, Version 1.0The Medipattern Corporation2005—
0 (this device)K052023Cadimas Version 1.0Alan Penn & Associates., Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199420
199510
199610
199810
200110
200220
200320
200420
FIG. 1 — Lineage of K052023, 1991–2005Source: 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
*K043216Cadstream Version 4.0
Summary page 1
…dical lmege Procc-smin >v:.fcn (.las.iticarn: ( lass II. Picture \rchivng and ( Zmmunicanon S' 'tem Sec. 21 I R. 892.2115(1 Predicate De%ice: CADStream m Version 4.0 (K043216) and B-CAD TM System Version 1.0 (K050846) and 3TP Software Option (K031350). Manufactured bh: Confirma. Inc. 821 Kirkland Avenu…
Confirma, Inc.2005—
*K050846B-Cad System, Version 1.0
Summary page 1
…carn: ( lass II. Picture \rchivng and ( Zmmunicanon S' 'tem Sec. 21 I R. 892.2115(1 Predicate De%ice: CADStream m Version 4.0 (K043216) and B-CAD TM System Version 1.0 (K050846) and 3TP Software Option (K031350). Manufactured bh: Confirma. Inc. 821 Kirkland Avenue Kirkland. WAA 98033: The Medipattem Corp…
The Medipattern Corporation2005—
*K0313503TP Software Option
Summary page 1
…and ( Zmmunicanon S' 'tem Sec. 21 I R. 892.2115(1 Predicate De%ice: CADStream m Version 4.0 (K043216) and B-CAD TM System Version 1.0 (K050846) and 3TP Software Option (K031350). Manufactured bh: Confirma. Inc. 821 Kirkland Avenue Kirkland. WAA 98033: The Medipattem Corporation 300 Sheppard Ave 'A Suite…
3tp, LLC20031

Also cleared against K043216: 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 14 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 8 other devices also cite its predicate K043216.

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?

CADimas VI.0 is indicated for processing of dynamic contrast enhanced MR images. CADimas VI.0 provides enhanced visualization for image interpretation.

Indications for use as stated in the FDA summary.

Also cleared against K043216

8 other devices cite the same predicate.

  • K211039BIT-MotionDde Mri Solutions, Ltd. · 2021
  • K090038Syngo BrevisSiemens Medical Solutions USA, Inc. · 2009
  • K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc. · 20091 recall
  • K081556Cadstream, Version 5.0Confirma, Inc. · 2009
  • K080196Z3D Contrast AcuityClario Medical Imaging, Inc. · 2008
  • K070244AEGISSentinelle Medical, Inc. · 2007

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/K052023 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052023: Cadimas Version 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052023

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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