510(k) · Cleared
Recalled · Class II · 2025Philips IntelliSpace Cardiovascular
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nethrlands BV · LLZ System, Image Processing, Radiological
Cleared on Nov 18, 2015 as substantially equivalent to K061995 (Philips Medical Systems North America Co., 2006) after a 34-day review. Its family tree reaches back 5 generations to 1996. 21 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 18, 2015
- Review
- 34 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954479 (1996). 10 ancestors in all, the oldest K954668 (1995). 21 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK954479 DicomviewHeartlab, Inc. · 1996
- 4 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- 3 generations backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- 2 generations backK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- 1 generation backK061995 XceleraPhilips Medical Systems North America Co. · 2006
- This deviceK153022 Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV · 2015
- Descendant · cites it directly · 19 of its ownK153736 3mensio WorkstationPie Medical Imaging BV · 2016 · Recalled
- Descendant · 2 generations on · 3 of its ownK202212 TruPlanCircle Cardiovascular Imaging, Inc. · 2021
- Descendant · 2 generations on · 2 of its ownK222593 TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK191585 iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK190874 Materialise Mimics EnlightMaterialise NV · 2019
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K1537363mensio WorkstationPie Medical Imaging BV · 2016 · cites it directly19descendants
- K202212TruPlanCircle Cardiovascular Imaging, Inc. · 2021 · 2 generations on3descendants
- K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc. · 2023 · 2 generations on2descendants
- K191585iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019 · 2 generations on2descendants
- K190874Materialise Mimics EnlightMaterialise NV · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| −4 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| −3 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| −2 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| −1 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| 0 (this device) | K153022 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nethrlands BV | 2015 | — |
| +1 | K153736 | 3mensio Workstation | Pie Medical Imaging BV | 2016 | 1 |
| +2 | K202212 | TruPlan | Circle Cardiovascular Imaging, Inc. | 2021 | — |
| +2 | K222593 | TruPlan Computed Tomography (CT) Imaging Software | Circle Cardiovascular Imaging, Inc. | 2023 | — |
| +2 | K191585 | iNtuition-Structural Heart Module | Terarecon,Inc. | 2019 | — |
| +2 | K190874 | Materialise Mimics Enlight | Materialise NV | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K061995 | XceleraSummary page 4…Manufacturer: Philips Medical Systems Nederland B.V. 510(k) clearance: K061995 Classification name Picture Archiving and Communications System… | 2006 |
What descends from it? (21)
See all 212 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 |
|---|---|---|---|---|
| Aug 8, 2025 | Class II | Z-2543-2025 | Software design | Software issue that results in the display of outdated information. |
| Apr 7, 2025 | Class II | Z-1740-2025 | Software in the Use Environment | An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report. |
| Apr 4, 2024 | Class II | Z-1252-2025 | Software design | Study data is not able to be archived, copied, or exported with the cardiovascular software version. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K153736 (Pie Medical Imaging BV, 2016) has gone furthest, with 19 descendants of its own.
- 6 other devices also cite its predicate K061995.
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?
Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology. Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of…
Read the full statement (170 words)
Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.
The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153022 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153022: Philips IntelliSpace Cardiovascular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153022
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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