510(k) · Cleared
ClearedZED Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zed Technologies · LLZ System, Image Processing, Radiological
Cleared on Apr 12, 2018 as substantially equivalent to K151957 (Box, Inc., 2015) after a 42-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Apr 12, 2018
- Review
- 42 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K954678 (1996). 24 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 5 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 4 generations backK012097 VortexUltravisual Medical Systems · 2001
- 3 generations backK061421 Erad PacsErad, Inc. · 2006
- 2 generations backK132799 Clariso PacsClariso, Inc. · 2013
- 1 generation backK151957 BOX DICOM ViewerBox, Inc. · 2015
- This deviceK180549 ZED LinkZed Technologies · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −6 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −5 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −4 | K012097 | Vortex | Ultravisual Medical Systems | 2001 | — |
| −3 | K061421 | Erad Pacs | Erad, Inc. | 2006 | — |
| −2 | K132799 | Clariso Pacs | Clariso, Inc. | 2013 | — |
| −1 | K151957 | BOX DICOM Viewer | Box, Inc. | 2015 | — |
| 0 (this device) | K180549 | ZED Link | Zed Technologies | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K151957 | BOX DICOM ViewerSummary page 4…Z Predicate Device: 21 CFR 807. 92(a)(3) Device Classification Name system, image processing, radiological 510(k) Number K151957 Device Name BOX DICOM Viewer Regulation Number 892.2050 C… | 2015 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K151957.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For…
Read the full statement (154 words)
ZED LINK™, is an image management system whose intended use is to provide scalable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all image modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation” and will include standard features and other tools for analyzing mammography images. Only pre-processed DICOM for presentation images can be interpreted for primary image diagnosis in mammography. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. ZED LINK™, is not intended for diagnostic image review on mobile devices. Typical users of this system are doctors and health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180549: ZED Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180549
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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