510(k) · Cleared
Recalled · 2008Philips Dsi System Release 3.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Cleared on Jul 17, 1992 after a 147-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 17, 1992
- Review
- 147 days
- Class
- Class II
- Product code
- IZJ
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK920793 Philips Dsi System Release 3.2Philips Medical Systems, Inc. · 1992
- Descendant · cites it directly · 0 of its ownK023440 Philips Digital Imaging Option Release 1Philips Medical Systems · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K023440Philips Digital Imaging Option Release 1Philips Medical Systems · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920793 | Philips Dsi System Release 3.2 | Philips Medical Systems, Inc. | 1992 | — |
| +1 | K023440 | Philips Digital Imaging Option Release 1 | Philips Medical Systems | 2002 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 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.
Planning a device in IZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K023440 | Philips Digital Imaging Option Release 1 | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2008 | Not classified | Z-2160-2008 | Software design | X-ray images may be stored in the wrong patient file or corrupted, images from two different patients may be combined in one patient's folder or may be combined on one image (corrupted). |
| Jan 4, 2008 | Not classified | Z-2406-2010 | Other | Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023440 (Philips Medical Systems, 2002) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IZJ devicesIZJ Camera, X-Ray, Fluorographic, Cine Or Spot: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZJ
FDA has decided no IZJ device since 2007.
Median 510(k) review, days · IZJ
Too few IZJ 510(k)s in any year since 2007 to give a median.
Recalls per year · IZJ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZJ
1in 2023
MAUDE reports naming product code IZJ, 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 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K920793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920793: Philips Dsi System Release 3.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K920793
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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