510(k) · Cleared
Recalled · Class II · 2019Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems
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 Feb 25, 1999 after a 65-day review. The FDA summary names its predicate without a number. 10 of the 267 devices in its family, counting itself, have a Class I recall. 266 later devices descend from it. It has been recalled 17 times.
- Decided
- Feb 25, 1999
- Review
- 65 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 17
- Predicates
- 0
266 later devices descend from it, 8 citing it directly. 10 of the 267 devices in this family, counting this one, have a Class I recall.
- This deviceK984545 Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000…Philips Medical Systems North America, Inc. · 1999
- Descendant · cites it directly · 136 of its ownK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 134 of its ownK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 133 of its ownK061871 Leica Model FL800Leica Microsystems, Inc. · 2006
- Descendant · 2 generations on · 131 of its ownK071037 Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 131 of its ownK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
Showing 5 of 266 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 266 · See all- K042961Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · cites it directly136descendants
- K060867Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · 2 generations on134descendants
- K061871Leica Model FL800Leica Microsystems, Inc. · 2006 · 2 generations on133descendants
- K071037Spy Intra-Operative Imaging System, Model SP2000Novadaq Technologies, Inc. · 2007 · 2 generations on131descendants
- K063345Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · 2 generations on131descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984545 | Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000)… | Philips Medical Systems North America, Inc. | 1999 | — |
| +1 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| +2 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| +2 | K061871 | Leica Model FL800 | Leica Microsystems, Inc. | 2006 | — |
| +2 | K071037 | Spy Intra-Operative Imaging System, Model SP2000 | Novadaq Technologies, Inc. | 2007 | 1 |
| +2 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 1 |
| 2014 | 14 | 0 |
| 2015 | 6 | 0 |
| 2016 | 10 | 1 |
| 2017 | 10 | 2 |
| 2018 | 13 | 0 |
| 2019 | 10 | 1 |
| 2020 | 14 | 1 |
| 2021 | 16 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 1 |
| 2024 | 22 | 2 |
| 2025 | 32 | 1 |
| 2026 | 29 | 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.
10 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 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? (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 |
|---|---|---|---|
| * | — | Philips Integris V5000 Named without a submission number | |
| * | — | Philips Integris H5000 Named without a submission number |
What descends from it? (266)
See all 2668 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042961 | Spy Intra-Operative Imaging System: SP2000 | 2005 | 136 |
| K020055 | Philips Integris Allura 9 with FD Option | 2002 | 124 |
| K031836 | Philips Fresco Release 1 | 2003 | 51 |
| K062647 | E-View Fluoroscopy System, Model CS-50 | 2006 | 10 |
| K070834 | CS-Series Fluoroscopy System, CS-10 Through CS-65 (11 Configurations) | 2007 | 9 |
| K130842 | Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura… Class I | 2013 | 0 |
| K041780 | New Brid | 2004 | 0 |
| K991922 | Digital Imaging System (BSR) | 1999 | 0 |
Has anything in its family been recalled? (10 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2019 | Class II | Z-1140-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Feb 19, 2019 | Class II | Z-1141-2019 | Component design/selection | Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or… |
| Sep 24, 2014 | Class II | Z-1280-2016 | Device Design | Loss of key image functionality due to a bent pedal of the Footswitch. |
| Oct 7, 2010 | Not classified | Z-1655-2011 | Nonconforming Material/Component | A wire in the connector of the Generator Grid Switch Supervisor box might short-circuit between 12V power and ground, and it will cause a System breakdown. |
| Feb 4, 2010 | Not classified | Z-2449-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem can only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator… |
| Feb 4, 2010 | Not classified | Z-2448-2010 | Software design | A lock-up might occur inside the Velara Generator due to intermittent shorts inside the system. The problem could only resolved by a warm or cold system restart. In exceptional cases the power converters of the KVmA unit in the generator… |
| Dec 10, 2008 | Not classified | Z-0344-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Dec 10, 2008 | Not classified | Z-0345-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Dec 10, 2008 | Not classified | Z-0346-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Dec 10, 2008 | Not classified | Z-0348-2009 | Radiation Control for Health and Safety Act | Tube failure occurs involving fluoroscopy of large patients and a partial failure of the grid switch. |
| Oct 23, 2008 | Not classified | Z-2475-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Oct 23, 2008 | Not classified | Z-2471-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Oct 23, 2008 | Not classified | Z-2473-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Oct 23, 2008 | Not classified | Z-2472-2010 | Other | A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display. |
| Dec 14, 2006 | Not classified | Z-0367-2007 | Other | Movement of the AD5 table or Lateral C-arm (LARC). The table and/or LARC will not move upon request, will move slowly when movement is requested or will not stop moving when requested. |
| 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. |
The 5 latest of 17 recalls; the web page lists all.
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.
- K130842Allura Xper FD or Table Series; Allura Xper FD10 Series; Allura Xper FD20 Series; Allura Xper FD Biplane…Philips Medical Systems Nederland B.V. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 111 Class I recalls
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 9 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K162859Allura Xper FD series and Allura Xper OR Table seriesPhilips Medical Systems Nederland B.V. · 2016 · 9 generations on · ◆ in the 2016 descendants bar of FIG. 112 Class I recalls
- K163715Allura Xper R9Philips Medical Systems Nederland B.V. · 2017 · 9 generations on · ◆ in the 2017 descendants bar of FIG. 17 Class I recalls
- K172822Azurion series R1.2Philips Medical Systems Nederland B.V. · 2017 · 10 generations on · ◆ in the 2017 descendants bar of FIG. 19 Class I recalls
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 10 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 · 10 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 · 10 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K200917Azurion R2.1Philips Medical Systems Nederland B.V. · 2020 · 11 generations on · ◆ in the 2020 descendants bar of FIG. 18 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K042961 (Novadaq Technologies, Inc., 2005) has gone furthest, with 136 descendants of its own.
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 Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.
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/K984545 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984545: Release 2 of Philips Integris Series (V5000, BV5000, H5000, BH5000, HM2000) Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984545
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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