510(k) · Cleared
Recalled · Class II · 2018Philips Integris H/HM System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · IZF System, X-Ray, Tomographic
Cleared on Dec 17, 1992 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it. It has been recalled 5 times.
- Decided
- Dec 17, 1992
- Review
- 57 days
- Class
- Class II
- Product code
- IZF
- Recalls
- 5
- Predicates
- 0
46 later devices descend from it, 1 citing it directly. 5 of the 47 devices in this family, counting this one, have a Class I recall.
- This deviceK925302 Philips Integris H/HM SystemPhilips Medical Systems, Inc. · 1992
- Descendant · cites it directly · 45 of its ownK982203 Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998
- Descendant · 2 generations on · 44 of its ownK033920 Caas II RvaPie Medical Imaging BV · 2004
- Descendant · 2 generations on · 43 of its ownK052988 CAASPie Medical Imaging BV · 2005
- Descendant · 3 generations on · 39 of its ownK063344 Caas Qca 3DPie Medical Imaging BV · 2006
- Descendant · 4 generations on · 38 of its ownK072591 Cardiop-B System, Version 2.1Paieon, Inc. · 2007
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K190106 Intra-Operative Positioning System; Simple Curve…7 generations on · 2019
- K242133 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K241243 Intra-Operative Positioning System (IOPS®)…8 generations on · 2024
- K230309 Intra-Operative Positioning System (IOPS®)…8 generations on · 2023
Most influential descendants
Showing 5 of 46 · See all- K982203Caas II Lva Biplane OptionPie Medical Equipment B.V. · 1998 · cites it directly45descendants
- K033920Caas II RvaPie Medical Imaging BV · 2004 · 2 generations on44descendants
- K052988CAASPie Medical Imaging BV · 2005 · 2 generations on43descendants
- K063344Caas Qca 3DPie Medical Imaging BV · 2006 · 3 generations on39descendants
- K072591Cardiop-B System, Version 2.1Paieon, Inc. · 2007 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925302 | Philips Integris H/HM System | Philips Medical Systems, Inc. | 1992 | — |
| +1 | K982203 | Caas II Lva Biplane Option | Pie Medical Equipment B.V. | 1998 | — |
| +2 | K033920 | Caas II Rva | Pie Medical Imaging BV | 2004 | — |
| +2 | K052988 | CAAS | Pie Medical Imaging BV | 2005 | — |
| +3 | K063344 | Caas Qca 3D | Pie Medical Imaging BV | 2006 | — |
| +4 | K072591 | Cardiop-B System, Version 2.1 | Paieon, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 1 |
| 2021 | 1 | 0 |
| 2023 | 4 | 1 |
| 2024 | 3 | 2 |
| 2025 | 4 | 1 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 devices in this family have 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 IZF device
- #1 K250850 Nanox.ARC Xscore 15.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (46)
See all 461 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982203 | Caas II Lva Biplane Option | 1998 | 45 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 16, 2018 | Class II | Z-3237-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3238-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Jul 16, 2018 | Class II | Z-3239-2018 | Device Design | There is a potential for the Monitor Ceiling Suspension, which holds a large screen monitor, may detach from the actuator rotor shaft causing the monitor to fall from the ground. When a Monitor Ceiling Suspension detaches from the… |
| Oct 12, 2005 | Not classified | Z-0206-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
| Oct 12, 2005 | Not classified | Z-0207-06 | Other | Potential for high voltage exposure involving the injector interface connector of patient support tables. |
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.
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 7 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 8 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 8 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K982203 (Pie Medical Equipment B.V., 1998) has gone furthest, with 45 descendants of its own.
How does its category compare?
All IZF devicesIZF System, X-Ray, Tomographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZF
Too few IZF 510(k)s in any year since 2007 to give a median.
Recalls per year · IZF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZF
1in 2021
MAUDE reports naming product code IZF, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 6 |
| 2011 | 0 | — | 0 | 24 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 1 | 0 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K925302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925302: Philips Integris H/HM System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925302
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026