510(k) · Cleared
Recalled · Class II · 2023Philips CombiDiagnost R90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Jan 31, 2017 as substantially equivalent to K031535 (Philips Medical Systems North America Co., 2003) after a 77-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 31, 2017
- Review
- 77 days
- Class
- Class II
- Product code
- JAA
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924593 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK924593 Diagnost 76 Family*R/F Systems - Release 4.4Philips Medical Systems, Inc. · 1992 · Recalled
- 2 generations backK970640 Philips Easy DiagnostPhilips Medical Systems North America, Inc. · 1997 · Recalled
- 1 generation backK031535 Philips Easydiagnost ElevaPhilips Medical Systems North America Co. · 2003 · Recalled
- This deviceK163210 Philips CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2017
- Descendant · cites it directly · 1 of its ownK203087 CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK232910 CombiDiagnost R90Philips Medical Systems Dmc GmbH · 2023 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924593 | Diagnost 76 Family*R/F Systems - Release 4.4 | Philips Medical Systems, Inc. | 1992 | 1 |
| −2 | K970640 | Philips Easy Diagnost | Philips Medical Systems North America, Inc. | 1997 | 5 |
| −1 | K031535 | Philips Easydiagnost Eleva | Philips Medical Systems North America Co. | 2003 | 15 |
| 0 (this device) | K163210 | Philips CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2017 | — |
| +1 | K203087 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2020 | 6 |
| +2 | K232910 | CombiDiagnost R90 | Philips Medical Systems Dmc GmbH | 2023 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203087 | CombiDiagnost R90 | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 3, 2023 | Class II | Z-1588-2023 | Radiation Control for Health and Safety Act | Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA). |
| Feb 11, 2022 | Class II | Z-1087-2024 | Software design | While performing a fluoroscopy examination, there is a potential that the Radio Fluoroscopy (RF) viewer will also display a previous patient's radiography images. If the issue occurs, there will be differences in image content, image… |
| Oct 21, 2021 | Class II | Z-1356-2023 | Device Design | If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from… |
| Oct 21, 2021 | Class II | Z-1355-2023 | Device Design | If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from… |
| Dec 19, 2019 | Class II | Z-1329-2020 | Software design | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the… |
| Dec 19, 2019 | Class II | Z-1328-2020 | Software design | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the… |
| Nov 7, 2018 | Class II | Z-0612-2019 | Software design (manufacturing process) | kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. |
| Oct 19, 2017 | Class II | Z-0330-2018 | Nonconforming Material/Component | The tube adapter-plate green/yellow protective earthing (PE) wire was removed. and spacers with different thickness were used to position pre-loc ring in respect to focal spot in specified distance. |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K203087 (Philips Medical Systems Dmc GmbH, 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031535.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163210: Philips CombiDiagnost R90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163210
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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