510(k) · Cleared
Recalled · 2008Diagnost 76 Family*R/F Systems - Release 4.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · IXL Device, Spot-Film
Cleared on Nov 24, 1992 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it. It has been recalled once.
- Decided
- Nov 24, 1992
- Review
- 75 days
- Class
- Class II
- Product code
- IXL
- Recalls
- 1
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK924593 Diagnost 76 Family*R/F Systems - Release 4.4Philips Medical Systems, Inc. · 1992
- Descendant · cites it directly · 7 of its ownK970640 Philips Easy DiagnostPhilips Medical Systems North America, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 6 of its ownK031535 Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003 · Recalled
- Descendant · 3 generations on · 2 of its ownK173433 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · Recalled
- Descendant · 3 generations on · 2 of its ownK163210 Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · Recalled
- Descendant · 4 generations on · 1 of its ownK212837 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · Recalled
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K970640Philips Easy DiagnostPhilips Medical Systems North America, Inc. · 1997 · cites it directly7descendants
- K031535Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003 · 2 generations on6descendants
- K173433ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018 · 3 generations on2descendants
- K163210Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017 · 3 generations on2descendants
- K212837ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924593 | Diagnost 76 Family*R/F Systems - Release 4.4 | Philips Medical Systems, Inc. | 1992 | — |
| +1 | K970640 | Philips Easy Diagnost | Philips Medical Systems North America, Inc. | 1997 | 5 |
| +2 | K031535 | Philips Easydiagnost Eleva | Philips Medical Systems North America Co. | 2003 | 15 |
| +3 | K173433 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2018 | 7 |
| +3 | K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017 | 8 |
| +4 | K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 IXL? 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970640 | Philips Easy Diagnost | 1997 | 7 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2008 | Not classified | Z-2404-2010 | 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, K970640 (Philips Medical Systems North America, Inc., 1997) has gone furthest, with 7 descendants of its own.
How does its category compare?
All IXL devicesIXL Device, Spot-Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXL
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXL
Too few IXL 510(k)s in any year since 2007 to give a median.
Recalls per year · IXL
2in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IXL
1in 2025
MAUDE reports naming product code IXL, 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 | — | 1 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 2 | 4 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 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 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K924593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924593: Diagnost 76 Family*R/F Systems - Release 4.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924593
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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