510(k) · Cleared
ClearedI4 (Integrated Intelligent Imaging Informatics) system
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · LLZ System, Image Processing, Radiological
Cleared on Feb 19, 2016 as substantially equivalent to K111804 (Philips Healthcare Informatics, Inc., 2011) after a 14-day review. Its family tree reaches back 7 generations to 1991. 3 later devices descend from it.
- Decided
- Feb 19, 2016
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K913770 (1991). 14 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- 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 backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 3 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 2 generations backK063267 Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · Recalled
- 1 generation backK111804 Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011 · Recalled
- This deviceK160315 I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016
- Descendant · cites it directly · 2 of its ownK173588 Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018
- Descendant · 2 generations on · 1 of its ownK250181 AV ViewerPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 3 generations on · 0 of its ownK261465 Indira Cloud ViewerIndigo Technologies · 2026
Most influential descendants
Showing 3 of 3 · See allView 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 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −3 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −2 | K063267 | Isite Pacs, V 4. X | Stentor Inc., A Philips Medical Systems Co. | 2006 | 4 |
| −1 | K111804 | Intellispace Pacs 4.X | Philips Healthcare Informatics, Inc. | 2011 | 2 |
| 0 (this device) | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | Philips Medical Systems Nederland B.V. | 2016 | — |
| +1 | K173588 | Illumeo System | Philips Medical Systems Technologies, Ltd. | 2018 | — |
| +2 | K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025 | — |
| +3 | K261465 | Indira Cloud Viewer | Indigo Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K111804 | Intellispace Pacs 4.XSummary page 5…me: IntelliSpace PACS 4.x Manufacturer: Philips Healthcare Informatics, Inc. 510(k) clearance: K111804 Classification name: Picture Archiving and Communications System Device class: Class… | 2011 |
| † | K032096 | Philips Viewforum 2003 | 2003 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K151598 | VesselNavigator Rel. 1.0 | 2015 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173588 | Illumeo System | 2018 | 2 |
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 25 years and passes through 7 companies; a new generation was cleared every 4.3 years on median.
- 6 of the 14 ancestors have a recall of any class.
- Of its descendants, K173588 (Philips Medical Systems Technologies, Ltd., 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K111804.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160315: I4 (Integrated Intelligent Imaging Informatics) system.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160315
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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