510(k) Report

510(k) · Cleared

Cleared

Communify Pacs Viewer

K120851510(k) TraditionalCleared Feb 19, 2013335-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

Communify Health, LLC · LLZ System, Image Processing, Radiological

Cleared on Feb 19, 2013 as substantially equivalent to K110797 (Flying Squirrel Storage, LLC, 2011) and 1 other predicate after a 335-day review. Its family tree reaches back 8 generations to 1996.

Decided
Feb 19, 2013
Review
335 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
2

Its longest line of descent runs back 8 generations to K954874 (1996). 57 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2006: 2 other ancestors2005: 1 other ancestor2003: 4 other ancestors2002: 3 other ancestors2004: 4 other ancestors2001: 7 other ancestors1998: 3 other ancestors1996: 5 other ancestors1994: 1 other ancestor1992: 2 other ancestors2000: 3 other ancestors1999: 1 other ancestor1997: 2 other ancestors1995: 2 other ancestors1993: 2 other ancestors1991: 4 other ancestors1990: 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 · recalledK071964 · Mim 4.1 (Seastar) · Mimvista Corp. · 2007 · recalled1985199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 11 other ancestors4 generations back: 13 other ancestors5 generations back: 11 other ancestors6 generations back: 8 other ancestors K071964 · Mim 4.1 (Seastar) · Mimvista Corp. · 2007 · recalledK060816 · 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 · 1996−50
  1. Root · 8 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
  2. 7 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
  3. 6 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
  4. 5 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
  5. 4 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
  6. 3 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
  7. 2 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
  8. 1 generation backK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
  9. This deviceK120851 Communify Pacs ViewerCommunify Health, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K954874Spectef ProtocolGE Medical Systems1996—
−7K980914Emory Cardiac Tool BoxEmory University1998—
−6K992450Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University1999—
−5K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc.2002—
−4K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc.2004—
−3K052379Mim 3.5 (Circa)Mimvista Corp.2005—
−2K060816Mim 4.0 (NeuroMimvista Corp.20061
−1K071964Mim 4.1 (Seastar)Mimvista Corp.20072
0 (this device)K120851Communify Pacs ViewerCommunify Health, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199140
199220
199320
199410
199520
199650
199720
199830
199910
200030
200170
200230
200340
200440
200510
200620
201110
FIG. 1 — Lineage of K120851, 1996–2013Source: 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? (2)

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
*K110797Communify Pacs Viewer
Summary page 1
…cturer Device SJO(k) Flying Squirrel Storage Communify PACS Viewer 1.0 K1 10797 MIM Software Inc. (formerly MlMvista Corp.) MlMviewer 4.1 K(071964 Comparison to Predi…
Flying Squirrel Storage, LLC2011—
*K071964Mim 4.1 (Seastar)
Summary page 1
…irrel Storage Communify PACS Viewer 1.0 K1 10797 MIM Software Inc. (formerly MlMvista Corp.) MlMviewer 4.1 K(071964 Comparison to Predicate Devices Communify PACS Viewer 1.5 is an extension of the Communify PACS Viewer 1.0 that i…
Mimvista Corp.20072

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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
  • 10 of the 57 ancestors have a recall of any class.

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. 2013, 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 Communify PACS Viewer 1.5 is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media CDICOM), DICOM-RT and non-DICOM information and data. The Communify PACS Viewer 1.5 is a software application that runs on standard "off-the-sheir" personal computers, business computers, and servers running standard operating systems. Communify PACS Viewer is an image and display software…

Read the full statement (208 words)

The Communify PACS Viewer 1.5 is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media CDICOM), DICOM-RT and non-DICOM information and data. The Communify PACS Viewer 1.5 is a software application that runs on standard "off-the-sheir" personal computers, business computers, and servers running standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM data from any OEM modality which supports DICOM standard imaging data; the system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulations, create graphical representations of anatomical areas, and perform quantitative measurements.

Communify PACS Viewer 1.5 is designed to support the use and viewing of DICOM-RT (radiotherapy extensions), such as Structure Set, Contour, Dose, Dose Value Histogram and Plan information.

In Communify PACS Viewer 1.5, mammographic images should only be viewed on mammography monitors that are cleared or approved by FDA. Users should not apply lossy compression to mammographic images and only DICOM "for presentation" mammography images may be displayed. Communify PACS Viewer 1.5 does not manipulate or edit any mammography image acquisition system manufacturer's proprietary image processing methods.

Please note that Communify PACS Viewer 1.5 does not run on mobile smartphones and tablets.

Indications for use as stated in the FDA summary.

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/K120851 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120851: Communify Pacs Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120851

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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