510(k) · Cleared
Recalled · Class II · 2019Philips Integris H5000
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 May 14, 1997 after a 30-day review. The FDA summary names no predicate by number. 1 later device descends from it. It has been recalled 17 times.
- Decided
- May 14, 1997
- Review
- 30 days
- Class
- Class II
- Product code
- IZI
- Recalls
- 17
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971365 Philips Integris H5000Philips 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 |
|---|---|---|---|---|---|
| 0 (this device) | K971365 | Philips Integris H5000 | 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|---|
| Dec 30, 2019 | Class II | Z-1491-2020 | Component design/selection | A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible. |
| Nov 3, 2015 | Class II | Z-0718-2016 | 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-0719-2016 | 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-0721-2016 | 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-0730-2016 | 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-0717-2016 | 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-0720-2016 | 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. |
| Feb 3, 2015 | Class II | Z-0347-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0349-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0354-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0353-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0348-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0350-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0351-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0352-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Feb 3, 2015 | Class II | Z-0346-2016 | Process control | Monitor Ceiling Suspension system may fall |
| Oct 10, 2003 | Not classified | Z-0099-04 | Other | The cable carrier and cables may fall after repeat collisions with OR lamps, radiation shields or other supported accessories. |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 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 | — |
https://510kreport.com/device/K971365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971365: Philips Integris H5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971365
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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