510(k) Report

510(k) · Cleared

Cleared

Viewing Client Mobile

K141536510(k) TraditionalCleared Mar 6, 2015269-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axon Medical Technologies Corp. · LLZ System, Image Processing, Radiological

Cleared on Mar 6, 2015 as substantially equivalent to K112930 (Mim Software, Inc., 2011) after a 269-day review. Its family tree reaches back 10 generations to 1996.

Decided
Mar 6, 2015
Review
269 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 10 generations to K954874 (1996). 38 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2000: 3 other ancestors1995: 2 other ancestors2004: 4 other ancestors2001: 4 other ancestors1999: 1 other ancestor1997: 2 other ancestors2002: 1 other ancestor1998: 1 other ancestor1996: 2 other ancestors1991: 3 other ancestors2003: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestorK954874 · Spectef Protocol · GE Medical Systems · 1996K980914 · Emory Cardiac Tool Box · Emory University · 1998K992450 · Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers · Emory University · 1999K014033 · Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers · Syntermed, Inc. · 2002K040141 · Emory Cardiac Toolbox Version 2.6 · Syntermed, Inc. · 2004K052379 · Mim 3.5 (Circa) · Mimvista Corp. · 2005K060816 · Mim 4.0 (Neuro · Mimvista Corp. · 2006 · recalledK062163 · Mimviewer · Mimvista Corp. · 2006K103785 · Mobile Mim · Mim Software, Inc. · 2011K112930 · Mobile Mim · Mim Software, Inc. · 20111985199019952000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors5 generations back: 3 other ancestors6 generations back: 6 other ancestors7 generations back: 9 other ancestors8 generations back: 7 other ancestors K112930 · Mobile Mim · Mim Software, Inc. · 2011K103785 · Mobile Mim · Mim Software, Inc. · 2011K062163 · Mimviewer · Mimvista Corp. · 2006K060816 · Mim 4.0 (Neuro · Mimvista Corp. · 2006 · recalledK052379 · Mim 3.5 (Circa) · Mimvista Corp. · 2005K040141 · Emory Cardiac Toolbox Version 2.6 · Syntermed, Inc. · 2004K014033 · Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers · Syntermed, Inc. · 2002K992450 · Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers · Emory University · 1999K980914 · Emory Cardiac Tool Box · Emory University · 1998K954874 · Spectef Protocol · GE Medical Systems · 1996−10−50
  1. Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 6 generations between
  3. 3 generations backK062163 MimviewerMimvista Corp. · 2006
  4. 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
  5. 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
  6. This deviceK141536 Viewing Client MobileAxon Medical Technologies Corp. · 2015
Show all 10 generations
  1. Root · 10 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 9 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
  3. 8 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
  4. 7 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
  5. 6 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
  6. 5 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
  7. 4 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
  8. 3 generations backK062163 MimviewerMimvista Corp. · 2006
  9. 2 generations backK103785 Mobile MimMim Software, Inc. · 2011
  10. 1 generation backK112930 Mobile MimMim Software, Inc. · 2011
  11. This deviceK141536 Viewing Client MobileAxon Medical Technologies Corp. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K954874Spectef ProtocolGE Medical Systems1996—
−9K980914Emory Cardiac Tool BoxEmory University1998—
−8K992450Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University1999—
−7K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc.2002—
−6K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc.2004—
−5K052379Mim 3.5 (Circa)Mimvista Corp.2005—
−4K060816Mim 4.0 (NeuroMimvista Corp.20061
−3K062163MimviewerMimvista Corp.2006—
−2K103785Mobile MimMim Software, Inc.2011—
−1K112930Mobile MimMim Software, Inc.2011—
0 (this device)K141536Viewing Client MobileAxon Medical Technologies Corp.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199130
199310
199520
199620
199720
199810
199910
200030
200140
200210
200310
200440
200510
FIG. 1 — Lineage of K141536, 1996–2015Source: 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 LLZ? 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 LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 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? (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
*K112930Mobile Mim
Summary page 4
…Processing Software Classification Name: Picture Archiving and Communication System (PACS), (21 CFR Part 892.2050, Product Code LLZ) 5.1.5 Predicate Devices K112930 MobileMIM MIM Software Inc. (formerly MIMvista Corp.) CONFIDENTIAL…
Mim Software, Inc.2011—

Also cleared against K112930: 5 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 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
  • 6 of the 38 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K112930.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

The Viewing Client Mobile is a software application that is intended to be used by qualified medical professionals for the review of medical images derived from multiple modalities. Clinical reports can also be viewed using this device. The Viewing Client Mobile application can be used to perform image manipulation (for example, window width and level, zoom, pan, rotation) and measurement. It can display both lossless and lossy compressed images. For…

Read the full statement (141 words)

The Viewing Client Mobile is a software application that is intended to be used by qualified medical professionals for the review of medical images derived from multiple modalities. Clinical reports can also be viewed using this device.

The Viewing Client Mobile application can be used to perform image manipulation (for example, window width and level, zoom, pan, rotation) and measurement. It can display both lossless and lossy compressed images. For lossy images, the user must determine if the level of loss is acceptable for their purposes.

The Viewing Client Mobile application provides wireless and portable access to medical images from only the following modalities: MRI, CT, X-ray and Ultrasound. It is not intended to replace a full workstation and should be used only when there is no access to one.

The Viewing Client Mobile application must not be used for mammography.

Indications for use as stated in the FDA summary.

Also cleared against K112930

5 other devices cite the same predicate.

  • K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016
  • K142196Visage Ease ProVisage Imaging GmbH · 2015
  • K133508Resolutionmd MobileCalgary Scientific, Inc. · 2014
  • K123357Onq RTSOncology Systems, Inc. · 2012
  • K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc. · 20127 recalls

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K141536 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141536: Viewing Client Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141536

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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