510(k) · Cleared
Recalled · Class II · 2019Merge PACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merge Healthcare Incorporated · LLZ System, Image Processing, Radiological
Cleared on Dec 8, 2017 as substantially equivalent to K082144 (Amicas, Inc., 2008) and 1 other predicate after a 29-day review. Its family tree reaches back 12 generations to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 8, 2017
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 12 generations to K913770 (1991). 116 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 8 generations between
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- This deviceK173475 Merge PACSMerge Healthcare Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK192455 Merge PACSMerge Healthcare Incorporated · 2019 · Recalled
Show all 12 generations
- Root · 12 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 11 generations backK963345 Advantage Windows Tissue Volume OptionGE Medical Systems · 1996
- 10 generations backK013381 Advanced Lung Analysis-1General Electric Co. · 2001
- 9 generations backK022013 Lungcare CT Software PackageSiemens Medical Solutions USA, Inc. · 2002
- 8 generations backK033374 Lungcare CT Software Package with Extended FunctionalitySiemens AG Medical Solutions · 2003
- 7 generations backK041484 UndecidedSiemens Medical Solutions USA, Inc. · 2004
- 6 generations backK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- 5 generations backK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- 4 generations backK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- 3 generations backK101228 Mirada XDMirada Medical, Ltd. · 2010
- 2 generations backK113244 Synapse MPR FusionFujifilm Medical System U.S.A., Inc. · 2011
- 1 generation backK160108 Synapse PACSFujifilm Medical Systems U.S.A, Inc. · 2016 · Recalled
- This deviceK173475 Merge PACSMerge Healthcare Incorporated · 2017
Most influential descendants
Showing 1 of 1 · See all- K192455Merge PACSMerge Healthcare Incorporated · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −11 | K963345 | Advantage Windows Tissue Volume Option | GE Medical Systems | 1996 | — |
| −10 | K013381 | Advanced Lung Analysis-1 | General Electric Co. | 2001 | — |
| −9 | K022013 | Lungcare CT Software Package | Siemens Medical Solutions USA, Inc. | 2002 | — |
| −8 | K033374 | Lungcare CT Software Package with Extended Functionality | Siemens AG Medical Solutions | 2003 | — |
| −7 | K041484 | Undecided | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −6 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| −5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| −3 | K101228 | Mirada XD | Mirada Medical, Ltd. | 2010 | — |
| −2 | K113244 | Synapse MPR Fusion | Fujifilm Medical System U.S.A., Inc. | 2011 | — |
| −1 | K160108 | Synapse PACS | Fujifilm Medical Systems U.S.A, Inc. | 2016 | 4 |
| 0 (this device) | K173475 | Merge PACS | Merge Healthcare Incorporated | 2017 | — |
| +1 | K192455 | Merge PACS | Merge Healthcare Incorporated | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 13 | 0 |
| 2002 | 12 | 0 |
| 2003 | 7 | 0 |
| 2004 | 10 | 0 |
| 2005 | 5 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K082144 | Amicas Pacs, Version 6.0Summary page 5…Page 5 === III. PREDICATE DEVICES Trade Name 510(k) Submitter 510(k) Number Primary Predicate Device: AMICAS, Inc. K082144 AMICAS PACS 6.0 Class II Pr… | 2008 |
| * | K160108 | Synapse PACSSummary page 5…Class II Product Code LLZ Synapse PACS Fujifilm Medical Systems K160108 U.S.A., Inc. Class II Pr… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192455 | Merge PACS | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 11, 2019 | Class II | Z-2062-2019 | Software Design Change | Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable… |
| Jul 11, 2019 | Class II | Z-2063-2019 | Software Design Change | Potential for prior thumbnails to not display in reverse chronological order and images may not scroll in reverse chronological order when mammography stacked scrolling is enabled. Merge PACS provides image manipulation tools to enable… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.5 years on median.
- 29 of the 116 ancestors have a recall of any class.
- Of its descendants, K192455 (Merge Healthcare Incorporated, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082144.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians…
Read the full statement (338 words)
Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, technologists, and other qualified medical professionals.
Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.
Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).
The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components.
The Patient Dashboard provides a composite view of patient data, both imaging and non-imaging. The optional Reach component provides clinicians with secure, proactive communication and access to clinical reports and images. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities.
Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging.
Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication.
Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images.
Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.
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/K173475 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173475: Merge PACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173475
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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