510(k) · Cleared
Recalled · 2004Philips Harmony Release 1
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 Oct 25, 2002 as substantially equivalent to K994210 (Philips Medical Systems, Inc., 2000) and 1 other predicate after a 64-day review. Its family tree reaches back 3 generations to 1996. 129 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 25, 2002
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 3 generations to K954479 (1996). 5 ancestors in all, the oldest K954668 (1995). 129 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK954479 DicomviewHeartlab, Inc. · 1996
- 2 generations backK972229 Imageview Coronary Angiography Display and Review SystemHeartware, Inc. · 1997
- 1 generation backK994210 Inturis SuitePhilips Medical Systems, Inc. · 2000
- This deviceK022788 Philips Harmony Release 1Philips Medical Systems North America Co. · 2002
- Descendant · cites it directly · 128 of its ownK061995 XceleraPhilips Medical Systems North America Co. · 2006
- Descendant · 2 generations on · 89 of its ownK083348 Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008
- Descendant · 3 generations on · 86 of its ownK090461 Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis…Tomtec Imaging Systems GmbH · 2009 · Recalled
- Descendant · 4 generations on · 82 of its ownK120135 2D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012
- Descendant · 4 generations on · 80 of its ownK110746 4D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011
Showing 5 of 129 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 129 · See all- K061995XceleraPhilips Medical Systems North America Co. · 2006 · cites it directly128descendants
- K083348Image-Arena ApplicationsTomtec Imaging Systems GmbH · 2008 · 2 generations on89descendants
- K090461Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0Tomtec Imaging Systems GmbH · 2009 · 3 generations on86descendants
- K1201352D Cardiac Performance Analysis MR 1.0Tomtec Imaging Systems GmbH · 2012 · 4 generations on82descendants
- K1107464D LV-Analysis 3.0Tomtec Imaging Systems GmbH · 2011 · 4 generations on80descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954479 | Dicomview | Heartlab, Inc. | 1996 | — |
| −2 | K972229 | Imageview Coronary Angiography Display and Review System | Heartware, Inc. | 1997 | — |
| −1 | K994210 | Inturis Suite | Philips Medical Systems, Inc. | 2000 | — |
| 0 (this device) | K022788 | Philips Harmony Release 1 | Philips Medical Systems North America Co. | 2002 | — |
| +1 | K061995 | Xcelera | Philips Medical Systems North America Co. | 2006 | — |
| +2 | K083348 | Image-Arena Applications | Tomtec Imaging Systems GmbH | 2008 | — |
| +3 | K090461 | Image-Arena 4.0 and IA Applications 2D Cardiac Performance Analysis 1.0 | Tomtec Imaging Systems GmbH | 2009 | 1 |
| +4 | K120135 | 2D Cardiac Performance Analysis MR 1.0 | Tomtec Imaging Systems GmbH | 2012 | — |
| +4 | K110746 | 4D LV-Analysis 3.0 | Tomtec Imaging Systems GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K994210 | Inturis SuiteSummary page 3…DICOM Q/R SCU Network Access Yes Yes Yes Regulatory Status K994210 K954668 Proposed Safety information: No new hazards are introduced by the… | 2000 |
| * | K954668 | HP Echo Image Management SystemSummary page 3…ICOM Q/R SCU Network Access Yes Yes Yes Regulatory Status K994210 K954668 Proposed Safety information: No new hazards are introduced by the development of “Harmony” soft… | 1995 |
What descends from it? (129)
See all 1291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061995 | Xcelera | 2006 | 128 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2004 | Not classified | Z-0640-05 | Other | Loss of image data from image repository and archive requiring patients to undergo repeat imaging. |
| Apr 15, 2004 | Not classified | Z-0973-04 | Other | Potential for the image data to be erased from the long term archive. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K061995 (Philips Medical Systems North America Co., 2006) has gone furthest, with 128 descendants of its own.
- 2 other devices also cite its predicate K994210.
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?
“Harmony”, is a suite of products comprised out of scalable levels of modular software programs, designed to perform the necessary functions required for the import, export, storage, archiving, review, analysis, reporting and database management of multimodality digital medical images.
‘‘Harmony” software will run on Intel based commercial hardware under Microsoft Windows based operating systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022788: Philips Harmony Release 1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022788
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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