510(k) · Cleared
ClearedRamsoft Pacs, Model 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ramsoft, Inc. · LLZ System, Image Processing, Radiological
Cleared on Aug 11, 2003 as substantially equivalent to K982563 (Ramsoft, Inc., 1998) and 2 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 11, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K955092 (1996). 5 ancestors in all, the oldest K925965 (1993). 6 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 2 generations backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- 1 generation backK982563 Ultrapro Model 98Ramsoft, Inc. · 1998
- This deviceK031562 Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK110797 Communify Pacs ViewerFlying Squirrel Storage, LLC · 2011
- Descendant · cites it directly · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK120851 Communify Pacs ViewerCommunify Health, LLC · 2013
- Descendant · cites it directly · 0 of its ownK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK063294 TopacsRadiological Specialists, Inc. · 2007
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K110797Communify Pacs ViewerFlying Squirrel Storage, LLC · 2011 · cites it directly1descendant
- K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010 · cites it directly1descendant
- K120851Communify Pacs ViewerCommunify Health, LLC · 2013 · 2 generations on0descendants
- K112008Touchpacs SuiteTouch Medical Solutions, Inc. · 2012 · cites it directly0descendants
- K063294TopacsRadiological Specialists, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −2 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| −1 | K982563 | Ultrapro Model 98 | Ramsoft, Inc. | 1998 | — |
| 0 (this device) | K031562 | Ramsoft Pacs, Model 3.0 | Ramsoft, Inc. | 2003 | — |
| +1 | K110797 | Communify Pacs Viewer | Flying Squirrel Storage, LLC | 2011 | — |
| +1 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| +2 | K120851 | Communify Pacs Viewer | Communify Health, LLC | 2013 | — |
| +1 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
| +1 | K063294 | Topacs | Radiological Specialists, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K982563 | Ultrapro Model 98Summary page 1…d Communication System (PACS) ClassificationName - LLZ - Image Processing System (8922050) Substantially Equivalent devices: Ultrapro98 (RamSoft Inc) - K982563 Kodak AutoRad (Kodak) - K955092 GE Advantage (General Electric Medical Systems) - K94120 Description: RamS… | 1998 |
| * | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print…Summary page 1…assificationName - LLZ - Image Processing System (8922050) Substantially Equivalent devices: Ultrapro98 (RamSoft Inc) - K982563 Kodak AutoRad (Kodak) - K955092 GE Advantage (General Electric Medical Systems) - K94120 Description: RamSoft PACS is a stand-alone software pa… | 1996 |
| * | K942120 | Advantage Windows Diagnostic X-Ray WorkstationSummary page 2…Comparisonto PredicateDevices Product Name GE Advantage Kodak AutoRad RamSoft Ultrapro 98 RamSoft PACS Windows (K942120) (K955092) K982563 (this… | 1994 |
What descends from it? (6)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K110797 (Flying Squirrel Storage, LLC, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
RamSofi PACS software is used with general purpose computing hardware to acquire, transmit, store and display images for clinical purposes. RamSofi PACS consists of one or more of image server, web server, database server, and workstations for interpretation, clinical review, quality control, video capturing, film digitizing, document scanning. Images may be acquired from imaging devices such as CR, CT, DX, MR, NM, PT, RF, US, XA, and other devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031562: Ramsoft Pacs, Model 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031562
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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