510(k) · Cleared
ClearedCommunify Pacs Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flying Squirrel Storage, LLC · LLZ System, Image Processing, Radiological
Cleared on Jul 20, 2011 as substantially equivalent to K063337 (Viztek, Inc., 2006) and 2 other predicates after a 120-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Jul 20, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K955092 (1996). 13 ancestors in all, the oldest K920319 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 3 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- 2 generations backK982563 Ultrapro Model 98Ramsoft, Inc. · 1998
- 1 generation backK031562 Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003
- This deviceK110797 Communify Pacs ViewerFlying Squirrel Storage, LLC · 2011
- Descendant · cites it directly · 0 of its ownK120851 Communify Pacs ViewerCommunify Health, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K120851Communify Pacs ViewerCommunify Health, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −3 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| −2 | K982563 | Ultrapro Model 98 | Ramsoft, Inc. | 1998 | — |
| −1 | K031562 | Ramsoft Pacs, Model 3.0 | Ramsoft, Inc. | 2003 | — |
| 0 (this device) | K110797 | Communify Pacs Viewer | Flying Squirrel Storage, LLC | 2011 | — |
| +1 | K120851 | Communify Pacs Viewer | Communify Health, LLC | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063337 | Opal-RadSummary page 2…ng: Manufacturer Device 510O(k) Viztek, Inc. Opal-RAD K063337 RamSoft, Inc. RamSoft PACS K031562 General Electric Medical Systems… | 2006 |
| * | K031562 | Ramsoft Pacs, Model 3.0Summary page 2…(k) Viztek, Inc. Opal-RAD K063337 RamSoft, Inc. RamSoft PACS K031562 General Electric Medical Systems Centricity PACS Plus K023557 Comparison to Predicate Devices The simi… | 2003 |
| * | K023557 | Centricity Pacs PlusSummary page 2…337 RamSoft, Inc. RamSoft PACS K031562 General Electric Medical Systems Centricity PACS Plus K023557 Comparison to Predicate Devices The similarity of Communify PACS Viewer with the predicate devices listed above is that they al… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120851 | Communify Pacs Viewer | 2013 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K120851 (Communify Health, LLC, 2013) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K063337.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data. The Communify PACS Viewer is a software application that runs on standard "off-the-shelf" personal computers, business computers, and servers running standard operating systems. Communify PACS Viewer is an image and display software that accepts DICOM…
Read the full statement (119 words)
The Communify PACS Viewer is a Picture Archiving and Communications System (PACS) viewer designed to be used to view Digital Imaging and Communications in Media (DICOM) and non-DICOM information and data. The Communify PACS Viewer is a software application that runs on standard "off-the-shelf" 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.
Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110797 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110797: 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/K110797
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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