# K173433: ProxiDiagnost N90

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Feb 5, 2018 after 95 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K924593 (1992). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031535: Philips Easydiagnost Eleva, Philips Medical Systems North America Co. (2003) Summary page 4.

## Most influential descendants
- K212837: ProxiDiagnost N90 (2021), 1 descendant of its own
- K233945: ProxiDiagnost N90 / Precision CRF (706110, 706400) (2024), 0 descendants of its own

## Recalls of this device
- Mar 3, 2023 · Class II · Z-1587-2023: 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 Admi
- Oct 21, 2022 · Class II · Z-1477-2023: 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
- Oct 21, 2021 · Class II · Z-1356-2023: 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 cabi
- Sep 22, 2021 · Class II · Z-0240-2022: 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 
- Dec 8, 2020 · Class II · Z-0727-2021: 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: 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 d
- Nov 20, 2019 · Class II · Z-3023-2020: Unexpected increase in peak tube potential (kV) will lead to an increased patient radiation dose.

## Indications for use
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.

Source page: https://510kreport.com/device/K173433
Methodology: https://510kreport.com/methodology