510(k) · Cleared
Recalled · Class II · 2019Intellispace Pacs 4.X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Healthcare Informatics, Inc. · LLZ System, Image Processing, Radiological
Cleared on Jul 28, 2011 as substantially equivalent to K063267 (Stentor Inc., A Philips Medical Systems Co., 2006) after a 31-day review. Its family tree reaches back 6 generations to 1991. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 28, 2011
- Review
- 31 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K913770 (1991). 13 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 5 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 4 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
- 3 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
- 2 generations backK043415 Centricity Pacs SystemGe Medical Systems Information Technologies · 2005 · Recalled
- 1 generation backK063267 Isite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. · 2006 · Recalled
- This deviceK111804 Intellispace Pacs 4.XPhilips Healthcare Informatics, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK160315 I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016
- Descendant · 2 generations on · 2 of its ownK173588 Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK250181 AV ViewerPhilips Medical Systems Nederland B.V. · 2025
- Descendant · 4 generations on · 0 of its ownK261465 Indira Cloud ViewerIndigo Technologies · 2026
- Descendant · cites it directly · 0 of its ownK182926 IntelliSpace RadiologyPhilips Healthcare Informatics, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K160315I4 (Integrated Intelligent Imaging Informatics) systemPhilips Medical Systems Nederland B.V. · 2016 · cites it directly3descendants
- K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd. · 2018 · 2 generations on2descendants
- K250181AV ViewerPhilips Medical Systems Nederland B.V. · 2025 · 3 generations on1descendant
- K261465Indira Cloud ViewerIndigo Technologies · 2026 · 4 generations on0descendants
- K182926IntelliSpace RadiologyPhilips Healthcare Informatics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −5 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −4 | K020483 | Advantage Workstation 4.1 | GE Medical Systems | 2002 | 2 |
| −3 | K033400 | Seno Advantage | Ge Medical Systems W-400 | 2003 | 6 |
| −2 | K043415 | Centricity Pacs System | Ge Medical Systems Information Technologies | 2005 | 23 |
| −1 | K063267 | Isite Pacs, V 4. X | Stentor Inc., A Philips Medical Systems Co. | 2006 | 4 |
| 0 (this device) | K111804 | Intellispace Pacs 4.X | Philips Healthcare Informatics, Inc. | 2011 | — |
| +1 | K160315 | I4 (Integrated Intelligent Imaging Informatics) system | Philips Medical Systems Nederland B.V. | 2016 | — |
| +2 | K173588 | Illumeo System | Philips Medical Systems Technologies, Ltd. | 2018 | — |
| +3 | K250181 | AV Viewer | Philips Medical Systems Nederland B.V. | 2025 | — |
| +4 | K261465 | Indira Cloud Viewer | Indigo Technologies | 2026 | — |
| +1 | K182926 | IntelliSpace Radiology | Philips Healthcare Informatics, Inc. | 2018 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K063267 | Isite Pacs, V 4. XSummary page 1…Class: 11 Product Code: LLZ 6.5 Substantial Equivalence Manufacturer: Stentor, Inc., a Philips Medical Systems Company Model: iSite PACS v4.x 510(k) Number: K063267 Philips Healthcare Informatics Page 6-1 of 6-3 510O(k) submission IntelliSpace… | 2006 |
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2019 | Class II | Z-2338-2020 | Device Design | Images may potentially become corrupt while using the system. |
| Jul 24, 2014 | Class II | Z-2252-2014 | Software design | A problem was detected in the Philips IntelliSpace PAC 4.4 software where if patient information is changed in the DICOM header and the study is exported before the image is updated in the PACS, the unchanged data may export causing the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K160315 (Philips Medical Systems Nederland B.V., 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K063267.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
IntelliSpace PACS 4.x is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The 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, communication and storage. Lossy…
Read the full statement (106 words)
IntelliSpace PACS 4.x is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The 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, communication and storage.
Lossy compressed mammographic images and digitized screen images must not be reviewed for primary image interpretations.
Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111804 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111804: Intellispace Pacs 4.X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111804
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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