510(k) · Cleared
ClearedPhilips Integris 3D RA Option
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America, Inc. · IZI System, X-Ray, Angiographic
Cleared on Dec 21, 1998 as substantially equivalent to K974367 (GE Medical Systems, 1998) after a 49-day review. Its family tree reaches back 1 generation to 1998. 1 of the 330 devices in its family, counting itself, has a Class I recall. 328 later devices descend from it.
- Decided
- Dec 21, 1998
- Review
- 49 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974367 (1998). 328 later devices descend from it, 2 citing it directly. 1 of the 330 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK974367 Advantx LCN, Advantx LCLPGE Medical Systems · 1998 · Recalled
- This deviceK983877 Philips Integris 3D RA OptionPhilips Medical Systems North America, Inc. · 1998
- Descendant · cites it directly · 244 of its ownK011447 IN Space 3DSiemens Medical Solutions USA, Inc. · 2001
- Descendant · 2 generations on · 218 of its ownK043469 Syngo Inspace 4DSiemens AG Medical Solutions · 2005
- Descendant · 3 generations on · 210 of its ownK071513 Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007
- Descendant · 3 generations on · 172 of its ownK062673 Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006
- Descendant · 3 generations on · 169 of its ownK062351 Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006
Showing 5 of 328 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 328 · See all- K011447IN Space 3DSiemens Medical Solutions USA, Inc. · 2001 · cites it directly244descendants
- K043469Syngo Inspace 4DSiemens AG Medical Solutions · 2005 · 2 generations on218descendants
- K071513Inspace 4D Software Package with Extended FunctionalitySiemens Medical Solutions · 2007 · 3 generations on210descendants
- K062673Modification to Syngo Inspace 4DSiemens AG Medical Solutions · 2006 · 3 generations on172descendants
- K062351Syngo Dual EnergySiemens Medical Solutions USA, Inc. · 2006 · 3 generations on169descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974367 | Advantx LCN, Advantx LCLP | GE Medical Systems | 1998 | 7 |
| 0 (this device) | K983877 | Philips Integris 3D RA Option | Philips Medical Systems North America, Inc. | 1998 | — |
| +1 | K011447 | IN Space 3D | Siemens Medical Solutions USA, Inc. | 2001 | — |
| +2 | K043469 | Syngo Inspace 4D | Siemens AG Medical Solutions | 2005 | — |
| +3 | K071513 | Inspace 4D Software Package with Extended Functionality | Siemens Medical Solutions | 2007 | — |
| +3 | K062673 | Modification to Syngo Inspace 4D | Siemens AG Medical Solutions | 2006 | — |
| +3 | K062351 | Syngo Dual Energy | Siemens Medical Solutions USA, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 15 | 0 |
| 2013 | 8 | 0 |
| 2014 | 15 | 0 |
| 2015 | 18 | 0 |
| 2016 | 13 | 0 |
| 2017 | 15 | 0 |
| 2018 | 20 | 0 |
| 2019 | 14 | 0 |
| 2020 | 27 | 0 |
| 2021 | 15 | 0 |
| 2022 | 27 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 0 |
| 2025 | 37 | 1 |
| 2026 | 27 | 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.
1 device in this family has a Class I recall. 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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 |
|---|---|---|---|
| * | K974367 | Advantx LCN, Advantx LCLPSummary page 1…ification name: Angiographic X-ray system, 21 CFR 892.1600 Class II (90 1ZI) Common/Usual name: Angiographic x-ray system Predicate Device(s): Advantx LCN+ and LCLP+ (K974367). Intended use: ‘ The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by… | 1998 |
What descends from it? (328)
See all 3282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The 3D RA Option is intended to assist physicians when analyzing two dimensional,
DSA X-ray images by creating three dimensional views from sets of two dimensional
images created during Rotational angiographic runs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983877: Philips Integris 3D RA Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983877
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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