510(k) · Cleared
ClearedTouchpacs Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Touch Medical Solutions, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jan 6, 2012 as substantially equivalent to K100236 (Stair Systems, Inc., 2010) and 3 other predicates after a 177-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jan 6, 2012
- Review
- 177 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K913770 (1991). 42 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 6 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 5 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 4 generations backK023003 Imagechecker-CT WorkstationR2 Technology, Inc. · 2002
- 3 generations backK032748 VITREA2, Version 3.4 Medical Image Processing SoftwareVital Images, Inc. · 2003 · Recalled
- 2 generations backK062164 Resolutionmd, Version 1.3Calgary Scientific, Inc. · 2006
- 1 generation backK100236 Stair Systems Pacs & Dicom ViewerStair Systems, Inc. · 2010
- This deviceK112008 Touchpacs SuiteTouch Medical Solutions, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −6 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −5 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −4 | K023003 | Imagechecker-CT Workstation | R2 Technology, Inc. | 2002 | — |
| −3 | K032748 | VITREA2, Version 3.4 Medical Image Processing Software | Vital Images, Inc. | 2003 | 2 |
| −2 | K062164 | Resolutionmd, Version 1.3 | Calgary Scientific, Inc. | 2006 | — |
| −1 | K100236 | Stair Systems Pacs & Dicom Viewer | Stair Systems, Inc. | 2010 | — |
| 0 (this device) | K112008 | Touchpacs Suite | Touch Medical Solutions, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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? (4)
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 |
|---|---|---|---|
| * | K100236 | Stair Systems Pacs & Dicom ViewerSummary page 1…redicate Devices: Manufacturer Device 510(k) STAIR Systems Inc. Stair Systems PACS & DICOM K100236 Viewer Ramsoft Inc. Ramsoft PACS K031562 Advan… | 2010 |
| * | K031562 | Ramsoft Pacs, Model 3.0Summary page 1…Stair Systems PACS & DICOM K100236 Viewer Ramsoft Inc. Ramsoft PACS K031562 Advance Imaging Solutions, LLC EZPACS K062878 Fuji Medical System USA Fuji Synapse… | 2003 |
| * | K062878 | Ezpacs, Version 3.0Summary page 1…Viewer Ramsoft Inc. Ramsoft PACS K031562 Advance Imaging Solutions, LLC EZPACS K062878 Fuji Medical System USA Fuji Synapse Workstation K051553 Software INT… | 2007 |
| * | K051553 | Fuji Synapse Workstation SoftwareSummary page 1…K031562 Advance Imaging Solutions, LLC EZPACS K062878 Fuji Medical System USA Fuji Synapse Workstation K051553 Software INTENDED USE STATEMENT The TouchPACS Suite software system is a picture archiving… | 2005 |
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 21 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 6 of the 42 ancestors have a recall of any class.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 TouchPACS Suite software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The TouchPACS Suite PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf personal computers, business computers, and servers running standard operating systems.…
Read the full statement (128 words)
The TouchPACS Suite software system is a picture archiving and communications system (PACS) intended to be used as a networked Digital Imaging and Communications in Medicine (DICOM) and non- DICOM information and data management system. The TouchPACS Suite PACS & DICOM Viewer Software is comprised of modular software programs that run on standard "off-the-shelf personal computers, business computers, and servers running standard operating systems. TouchPACS; TouchMGR Suite DICOM Viewer Software system is an image, data storage and display software that accepts DICOM data from any OEM modality which support DICOM standard imaging data. The system provides the capability to organize images generated by OEM vendor equipment, perform digital manipulation, create graphical representations of anatomical areas, and perform quantitative measurements.
The TouchPACS Suite software is not for mammographic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112008: Touchpacs Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112008
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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