510(k) · Cleared
ClearedICIS View
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · LLZ System, Image Processing, Radiological
Cleared on Jun 1, 2015 as substantially equivalent to K103785 (Mim Software, Inc., 2011) and 2 other predicates after a 187-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it.
- Decided
- Jun 1, 2015
- Review
- 187 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K954874 (1996). 42 ancestors in all, the oldest K885054 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 5 generations between
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK143397 ICIS ViewAgfa Healthcare N.V. · 2015
- Descendant · cites it directly · 3 of its ownK170434 Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK231662 Aid-UIaid · 2024
- Descendant · 2 generations on · 1 of its ownK200822 BraidBraid.Health · 2020
- Descendant · 2 generations on · 0 of its ownK252199 AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025
- Descendant · 2 generations on · 0 of its ownK250039 HPACSHealthhub · 2025
Show all 9 generations
- Root · 9 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 8 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 7 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 6 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 5 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 4 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 3 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 2 generations backK062163 MimviewerMimvista Corp. · 2006
- 1 generation backK103785 Mobile MimMim Software, Inc. · 2011
- This deviceK143397 ICIS ViewAgfa Healthcare N.V. · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V. · 2017 · cites it directly3descendants
- K231662Aid-UIaid · 2024 · cites it directly1descendant
- K200822BraidBraid.Health · 2020 · 2 generations on1descendant
- K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V. · 2025 · 2 generations on0descendants
- K250039HPACSHealthhub · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −8 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −7 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −6 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −5 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −4 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −3 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −2 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −1 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| 0 (this device) | K143397 | ICIS View | Agfa Healthcare N.V. | 2015 | — |
| +1 | K170434 | Enterprise Imaging XERO Viewer 8.1 | Agfa Healthcare N.V. | 2017 | 2 |
| +1 | K231662 | Aid-U | Iaid | 2024 | — |
| +2 | K200822 | Braid | Braid.Health | 2020 | — |
| +2 | K252199 | AGFA HealthCare Enterprise Imaging | Agfa Healthcare N.V. | 2025 | — |
| +2 | K250039 | HPACS | Healthhub | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K103785 | Mobile MimSummary page 4…is a 510(k) for Agfa’s ICIS® View software, a picture archiving and communications system. It is substantially equivalent to systems with MIM Software Inc.’s Mobile MIM (K103785-primary predicate), Agfa HealthCare’s IMPAX Workstation (K022292), and Client Outlook Inc.’s eUnity™ (K111164). B. DEVICE D… | 2011 |
| * | K022292 | Impax Diagnostic Display Station,Impax Clinical Review Station,Impax for Cardiology…Summary page 4…nd communications system. It is substantially equivalent to systems with MIM Software Inc.’s Mobile MIM (K103785-primary predicate), Agfa HealthCare’s IMPAX Workstation (K022292), and Client Outlook Inc.’s eUnity™ (K111164). B. DEVICE DESCRIPTION Agfa’s ICIS® View system is a picture archiving and co… | 2002 |
| * | K111164 | EunitySummary page 4…equivalent to systems with MIM Software Inc.’s Mobile MIM (K103785-primary predicate), Agfa HealthCare’s IMPAX Workstation (K022292), and Client Outlook Inc.’s eUnity™ (K111164). B. DEVICE DESCRIPTION Agfa’s ICIS® View system is a picture archiving and communication system (PACS), product code LLZ,… | 2011 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 7 of the 42 ancestors have a recall of any class.
- Of its descendants, K170434 (Agfa Healthcare N.V., 2017) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K103785.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.…
Read the full statement (172 words)
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.
Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups).
ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143397 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143397: ICIS View.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143397
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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