510(k) · Cleared
ClearedUltrapro Model 98
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 Oct 6, 1998 as substantially equivalent to K925965 (Advanced Light Imaging Technologies, Ltd., 1993) and 2 other predicates after a 75-day review. Its family tree reaches back 2 generations to 1996. 7 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K955092 (1996). 3 ancestors in all, the oldest K925965 (1993). 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK955092 Accurad Image Management System, Autorad, Regustration Station…Cemax-Icon, Inc. · 1996
- 1 generation backK963610 Aki Compacs Data Compresion Module for Diagnostic ImagesA.L.I. Technologies, Inc. · 1996
- This deviceK982563 Ultrapro Model 98Ramsoft, Inc. · 1998
- Descendant · cites it directly · 6 of its ownK031562 Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003
- Descendant · 2 generations on · 1 of its ownK110797 Communify Pacs ViewerFlying Squirrel Storage, LLC · 2011
- Descendant · 2 generations on · 1 of its ownK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK120851 Communify Pacs ViewerCommunify Health, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031562Ramsoft Pacs, Model 3.0Ramsoft, Inc. · 2003 · cites it directly6descendants
- K110797Communify Pacs ViewerFlying Squirrel Storage, LLC · 2011 · 2 generations on1descendant
- K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010 · 2 generations on1descendant
- K120851Communify Pacs ViewerCommunify Health, LLC · 2013 · 3 generations on0descendants
- K112008Touchpacs SuiteTouch Medical Solutions, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive… | Cemax-Icon, Inc. | 1996 | — |
| −1 | K963610 | Aki Compacs Data Compresion Module for Diagnostic Images | A.L.I. Technologies, Inc. | 1996 | — |
| 0 (this device) | K982563 | Ultrapro Model 98 | Ramsoft, Inc. | 1998 | — |
| +1 | K031562 | Ramsoft Pacs, Model 3.0 | Ramsoft, Inc. | 2003 | — |
| +2 | K110797 | Communify Pacs Viewer | Flying Squirrel Storage, LLC | 2011 | — |
| +2 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| +3 | K120851 | Communify Pacs Viewer | Communify Health, LLC | 2013 | — |
| +2 | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K925965 | Picture Archiving and Communication SystemsSummary page 1…Picture Archiving and Communication System 114 Class Systems, digital image communications - Class| 892.2020 LMD 12 Substantially Equivalent Devices ALl UltraPACS (K925965/A) with ALI comPACS data compression module (K963610) Manufactured by: ALl Technologies, Inc CEMAX-ICON Archive Manager 2.0 and… | 1993 |
| * | K963610 | Aki Compacs Data Compresion Module for Diagnostic ImagesSummary page 1…s Systems, digital image communications - Class| 892.2020 LMD 12 Substantially Equivalent Devices ALl UltraPACS (K925965/A) with ALI comPACS data compression module (K963610) Manufactured by: ALl Technologies, Inc CEMAX-ICON Archive Manager 2.0 and Autorad modules (K855092) Manufactured by: CEMAX-ICON… | 1996 |
| * | K955092 | Accurad Image Management System, Autorad, Regustration Station, Archive Server, Print… Our OCR of the scanned summary read K855092, FDA’s number for Life Corp. Oxygen Pac (Life Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “CEMAX-ICON Archive Manager 2.0 and Autorad modules”. | 1996 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031562 | Ramsoft Pacs, Model 3.0 | 2003 | 6 |
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 2 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K031562 (Ramsoft, Inc., 2003) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K925965.
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?
Ultrapro is a system that utilizes standard personal computer hardware to acquire, display, communicate and archive diagnostic images. The system is designed for use by medical professionals to acquire data from FDA listed imaging equipment such as ultrasound, CT and MRI scanners, x-ray imagers and video cassette recorders that provide a video output or a digital output. Archival is to be performed on media that is FDA listed.
Ultrapro can be configured to use JPEG lossy compression. When lossy compression is used, the compression ratio will be imprinted in the non-diagnostic area of the image. The compression ratio can be adjusted during acquisition.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982563 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982563: Ultrapro Model 98.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982563
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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