510(k) Report

510(k) · Cleared

Cleared

Rapidresults

K141881510(k) TraditionalCleared Oct 31, 2014112-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

Ramsoft, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 31, 2014 as substantially equivalent to K131977 (GE Healthcare, 2013) after a 112-day review. Its family tree reaches back 8 generations to 1994. 5 later devices descend from it.

Decided
Oct 31, 2014
Review
112 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K942120 (1994). 15 ancestors in all. 5 later devices descend from it, 2 citing it directly.

  1. Root · 8 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
  2. 7 generations backK013630 Isite RadiologyStentor, Inc. · 2001
  3. 6 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
  4. 5 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
  5. 4 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
  6. 3 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
  7. 2 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
  8. 1 generation backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
  9. This deviceK141881 RapidresultsRamsoft, Inc. · 2014
  10. Descendant · cites it directly · 3 of its ownK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
  11. Descendant · 2 generations on · 0 of its ownK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
  12. Descendant · 2 generations on · 0 of its ownK241546 aiCockpit AI ViewerFovia, Inc. · 2025
  13. Descendant · 2 generations on · 0 of its ownK242362 Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024
  14. Descendant · cites it directly · 0 of its ownK163158 MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd. · 2016

Most influential descendants

Showing 5 of 5 · See all
  • K222476OmegaAI Image ViewerRamsoft, Inc. · 2022 · cites it directly3descendants
  • K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026 · 2 generations on0descendants
  • K241546aiCockpit AI ViewerFovia, Inc. · 2025 · 2 generations on0descendants
  • K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb · 2024 · 2 generations on0descendants
  • K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K942120Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems1994—
−7K013630Isite RadiologyStentor, Inc.2001—
−6K031311Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc.2003—
−5K042313Integradweb MPR/MipDynamic Imaging, Inc.2004—
−4K082318Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions20087
−3K121387Centricity Pacs-IWGe Healthcare Integrated IT Solutions20121
−2K123174Centricity Pacs-IW with Universal ViewerGE Healthcare201210
−1K131977Centricity Universal Viewer Zero Footprint ClientGE Healthcare20138
0 (this device)K141881RapidresultsRamsoft, Inc.2014—
+1K222476OmegaAI Image ViewerRamsoft, Inc.2022—
+2K254237Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl.2026—
+2K241546aiCockpit AI ViewerFovia, Inc.2025—
+2K242362Lightning ViewerNexsys Electronics Inc. Dba Medweb2024—
+1K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200320
200410
200510
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
202210
202410
202510
202610
FIG. 1 — Lineage of K141881, 1994–2026Source: 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
*K131977Centricity Universal Viewer Zero Footprint Client
Summary page 4
…ST2 Windows 8 Pro Tablet). Common Name: Universal PACS Viewer Trade Name: RapidResults Classification: Class II, Produce Code LLZ Predicate Devices 510(k) Number: K131977 Device Name: Centricity Universal Viewer Zero Footprint client (ZFP) Company: GE Healthcare October 15, 2014…
GE Healthcare20138

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K222476OmegaAI Image ViewerRamsoft, Inc.20223
K163158MEDSYNAPSE Zero Footprint ViewerMedsynaptic Private, Ltd.20160

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 20 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
  • 6 of the 15 ancestors have a recall of any class.
  • Of its descendants, K222476 (Ramsoft, Inc., 2022) has gone furthest, with 3 descendants of its own.

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. 2014, 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?

This software displays medical images and associated documents. With appropriate display monitors, lighting, image quality, and level of lossy image compression, the software is intended for use as a primary diagnostic (on desktop platform) and non-diagnostic review tool (on mobile platform) for use by trained healthcare professionals. Each healthcare professional must determine if the level of loss is acceptable for their purpose. This software is not suitable for primary diagnosis of mammograms.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K141881: Rapidresults.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141881

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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