510(k) · Cleared
ClearedIntegris 3D-RA, Release 4.2
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 Feb 19, 2004 as substantially equivalent to K983877 (Philips Medical Systems North America, Inc., 1998) after a 15-day review. Its family tree reaches back 2 generations to 1998. 84 later devices descend from it.
- Decided
- Feb 19, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974367 (1998). 84 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK974367 Advantx LCN, Advantx LCLPGE Medical Systems · 1998 · Recalled
- 1 generation backK983877 Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc. · 1998
- This deviceK040254 Integris 3D-RA, Release 4.2Philips Medical Systems North America Co. · 2004
- Descendant · cites it directly · 51 of its ownK042334 Allura 3D-CA, Release 1Philips Medical Systems North America Co. · 2004
- Descendant · cites it directly · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · cites it directly · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 2 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
- Descendant · 3 generations on · 32 of its ownK121781 Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K042334Allura 3D-CA, Release 1Philips Medical Systems North America Co. · 2004 · cites it directly51descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · cites it directly49descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · cites it directly41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 2 generations on39descendants
- K121781Echonavigator Release 1Philips Medical Systems Nederland B.V. · 2012 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974367 | Advantx LCN, Advantx LCLP | GE Medical Systems | 1998 | 7 |
| −1 | K983877 | Philips Integris 3D RA Option | Philips Medical Systems North America, Inc. | 1998 | — |
| 0 (this device) | K040254 | Integris 3D-RA, Release 4.2 | Philips Medical Systems North America Co. | 2004 | — |
| +1 | K042334 | Allura 3D-CA, Release 1 | Philips Medical Systems North America Co. | 2004 | — |
| +1 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +1 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +2 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
| +3 | K121781 | Echonavigator Release 1 | Philips Medical Systems Nederland B.V. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 13 | 0 |
| 2026 | 9 | 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 |
|---|---|---|---|
| * | K983877 | Philips Integris 3D RA OptionSummary page 1…Predicate Device: The Integris 3D-RA release 4.2 device is substantially equivalent to the Integris 3D-RA release 1 (FDA ref. K983877.) Device Description: The Integris 3D-RA release 4.2 device allows the user to obtain a three dimens… | 1998 |
What descends from it? (84)
See all 846 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 6 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K042334 (Philips Medical Systems North America Co., 2004) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K983877.
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?
The Integris 3D-RA release 4.2 is intended to assist the physicians when analyzing 2-Dimensional, DSA X-ray images by creating 3-Dimensional views from sets of 2-Dimensional images created during rotational angiographic runs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040254: Integris 3D-RA, Release 4.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040254
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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