510(k) · Cleared
Recalled · Class II · 2015Philips Integris V5000 and BV5000
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 Nov 10, 1997 as substantially equivalent to K910370 (Philips Medical Systems, Inc., 1991) after a 56-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Nov 10, 1997
- Review
- 56 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910370 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK910370 Philips Integris V3000 and V4000Philips Medical Systems, Inc. · 1991
- This deviceK973482 Philips Integris V5000 and BV5000Philips Medical Systems North America, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK092713 Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K092713Spectre Wireless Encrypted Footswitch and Hand Switch SystemTransamerican Medical Imaging · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910370 | Philips Integris V3000 and V4000 | Philips Medical Systems, Inc. | 1991 | — |
| 0 (this device) | K973482 | Philips Integris V5000 and BV5000 | Philips Medical Systems North America, Inc. | 1997 | — |
| +1 | K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch System | Transamerican Medical Imaging | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 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 IZI? 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 |
|---|---|---|---|
| * | K910370 | Philips Integris V3000 and V4000Summary page 1…tion name: Angiographic X-ray system, 21 CFR 892.1600 Class I1 (90 1Z]) Common/Usual name: Angiographic x-ray system Predicate Device(s): Philips Integris V3000 ( Re.: K910370) Intended use: The Philips INTEGRIS V5000 and BV5000 system family is intended for use in dedicated vascular and neurovascular… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092713 | Spectre Wireless Encrypted Footswitch and Hand Switch System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2015 | Class II | Z-0722-2016 | Device Design | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Nov 3, 2015 | Class II | Z-0723-2016 | Device Design | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Nov 3, 2015 | Class II | Z-0724-2016 | Device Design | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
| Nov 3, 2015 | Class II | Z-0725-2016 | Device Design | The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K092713 (Transamerican Medical Imaging, 2010) has gone furthest, with 0 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 V5000 and BV5000 system family is intended for use in
dedicated vascular and neurovascular applications, including diagnostic and
interventional procedures.
This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography as well
as PTA’s stent placements, embolisations, and thrombolysis. The systems are also
intended for use in mixed cardiac/vascular/neuro applications and also non vascular
interventions.
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/K973482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973482: Philips Integris V5000 and BV5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973482
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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