510(k) · Cleared
ClearedCci Pacs Viewer (Pacs-US-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CliniComp, Intl. · LLZ System, Image Processing, Radiological
Cleared on Apr 23, 2026 as substantially equivalent to K203104 (Merge Healthcare Incorporated, 2021) and 1 other predicate after a 115-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Apr 23, 2026
- Review
- 115 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K942120 (1994). 41 ancestors in all, the oldest K904519 (1991). No later device cites it as a predicate yet.
- Root · 10 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 6 generations between
- 3 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 2 generations backK141881 RapidresultsRamsoft, Inc. · 2014
- 1 generation backK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- This deviceK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
Show all 10 generations
- Root · 10 generations backK942120 Advantage Windows Diagnostic X-Ray WorkstationGE Medical Systems · 1994
- 9 generations backK013630 Isite RadiologyStentor, Inc. · 2001
- 8 generations backK031311 Integradweb by Dynamic Imaging, Inc.Dynamic Imaging, Inc. · 2003
- 7 generations backK042313 Integradweb MPR/MipDynamic Imaging, Inc. · 2004
- 6 generations backK082318 Centricity Pacs IWGe Healthcare Dynamic Imaging Solutions · 2008 · Recalled
- 5 generations backK121387 Centricity Pacs-IWGe Healthcare Integrated IT Solutions · 2012 · Recalled
- 4 generations backK123174 Centricity Pacs-IW with Universal ViewerGE Healthcare · 2012 · Recalled
- 3 generations backK131977 Centricity Universal Viewer Zero Footprint ClientGE Healthcare · 2013 · Recalled
- 2 generations backK141881 RapidresultsRamsoft, Inc. · 2014
- 1 generation backK222476 OmegaAI Image ViewerRamsoft, Inc. · 2022
- This deviceK254237 Cci Pacs Viewer (Pacs-US-001)CliniComp, Intl. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K942120 | Advantage Windows Diagnostic X-Ray Workstation | GE Medical Systems | 1994 | — |
| −9 | K013630 | Isite Radiology | Stentor, Inc. | 2001 | — |
| −8 | K031311 | Integradweb by Dynamic Imaging, Inc. | Dynamic Imaging, Inc. | 2003 | — |
| −7 | K042313 | Integradweb MPR/Mip | Dynamic Imaging, Inc. | 2004 | — |
| −6 | K082318 | Centricity Pacs IW | Ge Healthcare Dynamic Imaging Solutions | 2008 | 7 |
| −5 | K121387 | Centricity Pacs-IW | Ge Healthcare Integrated IT Solutions | 2012 | 1 |
| −4 | K123174 | Centricity Pacs-IW with Universal Viewer | GE Healthcare | 2012 | 10 |
| −3 | K131977 | Centricity Universal Viewer Zero Footprint Client | GE Healthcare | 2013 | 8 |
| −2 | K141881 | Rapidresults | Ramsoft, Inc. | 2014 | — |
| −1 | K222476 | OmegaAI Image Viewer | Ramsoft, Inc. | 2022 | — |
| 0 (this device) | K254237 | Cci Pacs Viewer (Pacs-US-001) | CliniComp, Intl. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K203104 | IBM iConnect AccessSummary page 5…ocessing Software Regulation Number: 21 CFR 892.2050 Product Code(s): LLZ Legally Marketed Predicate Device: Predicate Device: IBM iConnect Access, K203104 Product Code: LLZ, Regulation Number: 21 CFR 892.2050 Reference Device: OmegaAI Image Viewer, K222476, Product Code:… | 2021 |
| * | K222476 | OmegaAI Image ViewerSummary page 5…Device: Predicate Device: IBM iConnect Access, K203104 Product Code: LLZ, Regulation Number: 21 CFR 892.2050 Reference Device: OmegaAI Image Viewer, K222476, Product Code: LLZ, Regulation Number: 21 CFR 892.2050… | 2022 |
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 32 years and passes through 8 companies; a new generation was cleared every 3.4 years on median.
- 13 of the 41 ancestors have a recall of any class.
- 1 other device also cites its predicate K203104.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 CCI PACS VIEWER is a software-based Medical Image Management and Processing System (MIMPS) intended to archive, distribute, retrieve, process, and display medical images and associated data from DICOM-compliant modalities and hospital information systems. The device provides healthcare professional tools to aid in the review, analysis, and interpretation of medical images through interactive display, manipulation, measurement, annotation, and…
Read the full statement (300 words)
The CCI PACS VIEWER is a software-based Medical Image Management and Processing System (MIMPS) intended to archive, distribute, retrieve, process, and display medical images and associated data from DICOM-compliant modalities and hospital information systems.
The device provides healthcare professional tools to aid in the review, analysis, and interpretation of medical images through interactive display, manipulation, measurement, annotation, and comparison of images from supported modalities (CT, MR, PET, US, X-Ray).
It is intended for use by trained and licensed healthcare professionals whose scope of practice includes the review or interpretation of medical images. This includes radiologists for primary diagnostic interpretation, and physicians or qualified medical technicians for clinical review, analysis, and consultation. Users must have completed appropriate training on the software’s functions, capabilities, and limitations.
The system supports visualization and qualitative assessment of anatomical structures across images from major modalities, including spatial review within a single study and side-by-side or linked comparison of serial examinations. It is designed to assist healthcare providers in conjunction with primary diagnostics performed by a certified radiologist, or during direct consultation with a radiologist. The software is not intended to replace the independent skill, judgment, or diagnosis of a qualified medical practitioner.
The device is not intended for primary diagnostic interpretation of mammography images or lossy compressed images that do not meet clinical quality requirements for the intended use.
The CCI PACS VIEWER operates on a cloud-based virtual platform with a Windows operating system and is accessible via compliant HTML5 browsers on desktop, laptop, or mobile tablet devices.
• For primary diagnostic interpretation, display monitors must be FDA-cleared for diagnostic use (where required by regulation) and maintained under a documented quality control program compliant with applicable standards.
• CCI PACS VIEWER application on mobile devices such as iPhones and iPads is not intended for diagnostic use.
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/K254237 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254237: Cci Pacs Viewer (Pacs-US-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254237
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026