510(k) · Cleared
ClearedMEDSYNAPSE Zero Footprint Viewer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medsynaptic Private, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 2, 2016 as substantially equivalent to K141881 (Ramsoft, Inc., 2014) after a 22-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Dec 2, 2016
- Review
- 22 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K942120 (1994). 16 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 5 generations between
- 3 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 2 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 1 generation backK141881 RapidresultsRamsoft, Inc. · 2014
- This deviceK163158 MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd. · 2016
Show all 9 generations
- Root · 9 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 8 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 7 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 6 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 5 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 4 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 3 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 2 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 1 generation backK141881 RapidresultsRamsoft, Inc. · 2014
- This deviceK163158 MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −8 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −7 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −6 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −5 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −4 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −3 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| −2 | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | 8 |
| −1 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| 0 (this device) | K163158 | MEDSYNAPSE Zero Footprint Viewer | Medsynaptic Private, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141881 | RapidresultsSummary page 4…system, Product code LLZ, Regulation: 892.2050 Class of device: Class II. 2. The legally marketed device to which we are claiming equivalence: RapidResults, K141881, RamSoft, Inc. Common Name: PACS Software Classification Name: System, image processing, radiological Regulat… | 2014 |
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 22 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 16 ancestors have a recall of any class.
- 1 other device also cites its predicate K141881.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
With appropriate display monitors, lighting, image quality, and level of lossy image compression the use of MEDSYNAPSE ZERO FOOTPRINT VIEWER is to distribute medical images & associated documents on desktop (Windows & Linux) & mobile platform (Android, iOS, Blackberry, Windows) using browsers like Internet Explorer, Mozilla Firefox, Safari, UC Browser or Google Chrome within or out of hospital. The users of the systems will be trained healthcare professionals. This software is not appropriate for primary diagnosis of Mammograms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163158 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163158: MEDSYNAPSE Zero Footprint Viewer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163158
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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