510(k) · Cleared
Recalled · Class II · 2023ProxiDiagnost N90
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · OWB Interventional Fluoroscopic X-Ray System
Cleared on Feb 5, 2018 as substantially equivalent to K031535 (Philips Medical Systems North America Co., 2003) after a 95-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Feb 5, 2018
- Review
- 95 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 7
- 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 deviceK173433 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2018
- Descendant · cites it directly · 1 of its ownK212837 ProxiDiagnost N90Philips Medical Systems Dmc GmbH · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK233945 ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH · 2024 · 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) | K173433 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2018 | — |
| +1 | K212837 | ProxiDiagnost N90 | Philips Medical Systems Dmc GmbH | 2021 | 5 |
| +2 | K233945 | ProxiDiagnost N90 / Precision CRF (706110, 706400) | Philips Medical Systems Dmc GmbH | 2024 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K031535 | Philips Easydiagnost ElevaSummary page 4…hilips EasyDiagnost Eleva Manufacturer: Philips Medical System DMC 510(k) Clearance: K031535 – June 17, 2003 Classification Name: Image-intensified fluoroscopic x-ray… | 2003 |
| † | K163210 | Philips CombiDiagnost R90 | 2017 |
| † | K153318 | Philips Eleva Workspot with SkyFlow | 2015 |
| † | K170113 | pixium 4343RCE | 2017 |
| † | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | 2017 |
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 |
|---|---|---|---|
| K212837 | ProxiDiagnost N90 | 2021 | 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-1587-2023 | 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). |
| Oct 21, 2022 | Class II | Z-1477-2023 | Component design/selection | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the… |
| 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… |
| Sep 22, 2021 | Class II | Z-0240-2022 | Radiation Control for Health and Safety Act | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control… |
| Dec 8, 2020 | Class II | Z-0727-2021 | Radiation Control for Health and Safety Act | After the user selects the Lock-in command, the kV and mA values are not locked immediately and can adjust if the collimator shutter position is changed directly after the Lock-in command. |
| Apr 23, 2020 | Class II | Z-2256-2020 | Process control | The thermo switches in the three-phase transformer, which normally aid in powering down the System Power Distribution Unit, may be incorrectly installed and not working. If the transformer overheats due to a first failure and the thermo… |
| Nov 20, 2019 | Class II | Z-3023-2020 | Radiation Control for Health and Safety Act | Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose. |
The 5 latest of 7 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 26 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, K212837 (Philips Medical Systems Dmc GmbH, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K031535.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
ProxiDiagnost N90 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/K173433 · printed Nov 5, 2026
Cite this page
510(k) Report. “K173433: ProxiDiagnost N90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K173433
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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