510(k) · Cleared
ClearedXcelera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · LLZ System, Image Processing, Radiological
Cleared on Sep 6, 2006 as substantially equivalent to K022788 (Philips Medical Systems North America Co., 2002) and 1 other predicate after a 54-day review. Its family tree reaches back 4 generations to 1996. 128 later devices descend from it.
- Decided
- Sep 6, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K954479 (1996). 9 ancestors in all, the oldest K954668 (1995). 128 later devices descend from it, 7 citing it directly.
- Root · 4 generations backK954479 DicomviewHeartlab, Inc. · 1996
- 3 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- 2 generations backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- 1 generation backK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002 · Recalled
- This deviceK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · cites it directly · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- Descendant · 2 generations on · 86 of its ownK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- Descendant · 3 generations on · 82 of its ownK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- Descendant · 3 generations on · 80 of its ownK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
- Descendant · cites it directly · 80 of its ownK110667 Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2011
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · See all- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · cites it directly89descendants
- K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH · 2009 · 2 generations on86descendants
- K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012 · 3 generations on82descendants
- K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011 · 3 generations on80descendants
- K110667Image-Arena and Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2011 · cites it directly80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| −3 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| −2 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| −1 | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | 2 |
| 0 (this device) | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +1 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| +2 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| +3 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| +3 | K110746 | 4D LV-Analysis 3.0 | Tomtec Imaging Systems GmbH | 2011 | — |
| +1 | K110667 | Image-Arena and Image-Arena Applications | Tomtec Imaging Systems GmbH | 2011 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 11 | 0 |
| 2023 | 12 | 0 |
| 2024 | 11 | 0 |
| 2025 | 23 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K022788 | Philips Harmony Release 1Summary page 2…e result in any new potential hazard. Philips Medical Systems considers the Xcelera to be substantially equivalent to the Philips Medical Systems, Harmony (K022788) and the Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation (K042203). DEPARTMENTOF… | 2002 |
| * | K042203 | Leonardo Syngo Cardiology WorkstationSummary page 2…be substantially equivalent to the Philips Medical Systems, Harmony (K022788) and the Siemens Medical Systems Inc., LEONARDO syngo Cardiology Workstation (K042203). DEPARTMENTOFHEALTH&HUMANSERVICES… | 2004 |
What descends from it? (128)
See all 1287 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)
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 10 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K083348 (Tomtec Imaging Systems GmbH, 2008) has gone furthest, with 89 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving/ review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.…
Read the full statement (205 words)
Philips Xcelera software is an integrated multimodality image and information system, designed to perform the necessary functions required for import /export/ storage / archiving/ review / analysis/ quantification (for example: area, circumference, volume, velocity, length, percent, time, ejection fraction, pressure gradient, LV volumes) / reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.
Xcelera offers support for third party plug-ins in order to enable the use of commercially available tools and for analysis, quantification and reporting Xcelera offers support to launch specified 3 rd party programs from the user interface (Desktop Integration).
It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.
Philips Xcelera software runs on standard information technology hardware and software. The Xcelera proprietary software product utilizes the standard Microsoft Windows Operating System and user interface. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Philips Xcelera will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.
Thre 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/K061995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061995: Xcelera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061995
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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