510(k) · Cleared
ClearedPhilips IntelliSpace Cardiovascular
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 Oct 2, 2025 as substantially equivalent to K153022 (Philips Medical Systems Nethrlands BV, 2015) after a 167-day review. Its family tree reaches back 6 generations to 1996.
- Decided
- Oct 2, 2025
- Review
- 167 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954479 (1996). 11 ancestors in all, the oldest K954668 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK954479 DicomviewHeartlab, Inc. · 1996
- 5 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- 4 generations backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- 3 generations backK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- 2 generations backK061995 XceleraPhilips Medical Systems North America Co. · 2006
- 1 generation backK153022 Philips IntelliSpace CardiovascularPhilips Medical Systems Nethrlands BV · 2015 · Recalled
- This deviceK251215 Philips IntelliSpace CardiovascularPhilips Medical Systems Nederland B.V. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| −5 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| −4 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| −3 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| −2 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| −1 | K153022 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nethrlands BV | 2015 | 3 |
| 0 (this device) | K251215 | Philips IntelliSpace Cardiovascular | Philips Medical Systems Nederland B.V. | 2025 | — |
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 |
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 |
|---|---|---|---|
| * | K153022 | Philips IntelliSpace CardiovascularSummary page 5…e management and processing system Product Code LLZ Regulation Number 21 CFR 892.2050 Predicate Device Philips IntelliSpace Cardiovascular (K153022) 1. Device Description and Technological Characteristics Philips IntelliSpace Cardiovascular is a comprehensive cardiac image an… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 6 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K153022.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K251215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251215: 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/K251215
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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