510(k) · Cleared
ClearedIntelliSpace Portal Platform
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederlands B.V. · LLZ System, Image Processing, Radiological
Cleared on Oct 18, 2016 as substantially equivalent to K081985 (Ge Medical Systems, LLC, 2008) after an 88-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Oct 18, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945188 (1995). 17 ancestors in all, the oldest K871859 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK945188 Cemax Vipstation and/or SoftwareCemax, Inc. · 1995
- 4 generations backK961023 Aidp (Accuimage Image Display Processor)Accuimage, Inc. · 1996
- 3 generations backK994329 Iivs Integrated Image Viewing StationTerarecon,Inc. · 2000
- 2 generations backK012086 Aquariusnet ServerTerarecon,Inc. · 2001
- 1 generation backK081985 AW ServerGe Medical Systems, LLC · 2008 · Recalled
- This deviceK162025 IntelliSpace Portal PlatformPhilips Medical Systems Nederlands B.V. · 2016
- Descendant · cites it directly · 0 of its ownK200899 Quantib AI NodeQuantib B.V. · 2020
Most influential descendants
Showing 1 of 1 · See all- K200899Quantib AI NodeQuantib B.V. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945188 | Cemax Vipstation and/or Software | Cemax, Inc. | 1995 | — |
| −4 | K961023 | Aidp (Accuimage Image Display Processor) | Accuimage, Inc. | 1996 | — |
| −3 | K994329 | Iivs Integrated Image Viewing Station | Terarecon,Inc. | 2000 | — |
| −2 | K012086 | Aquariusnet Server | Terarecon,Inc. | 2001 | — |
| −1 | K081985 | AW Server | Ge Medical Systems, LLC | 2008 | 5 |
| 0 (this device) | K162025 | IntelliSpace Portal Platform | Philips Medical Systems Nederlands B.V. | 2016 | — |
| +1 | K200899 | Quantib AI Node | Quantib B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K081985 | AW ServerSummary page 4…tion name: Picture Archiving and Communications System Device classification: Class II 510(k) clearance number: K081985 Premarket Notification [510(k)] Submission Page: 5-2 IntelliSpace Portal Platform Philip… | 2008 |
| † | K060937 | Brilliance Volume | 2006 |
| † | K130278 | MR Permeability | 2013 |
| † | K032096 | Philips Viewforum 2003 | 2003 |
| † | K111804 | Intellispace Pacs 4.X | 2011 |
| † | K111336 | EBW NM 2.0 | 2011 |
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 |
|---|---|---|---|
| K200899 | Quantib AI Node | 2020 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 6 of the 17 ancestors have a recall of any class.
- Of its descendants, K200899 (Quantib B.V., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K081985.
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?
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications .
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162025: IntelliSpace Portal Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162025
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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