# K212837: ProxiDiagnost N90

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Sep 21, 2021 after 14 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924593 (1992). 4 ancestors in all.
1 later device descends 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)
- K173433: ProxiDiagnost N90, Philips Medical Systems Dmc GmbH (2018) Summary page 4.

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

## Recalls of this device
- Dec 15, 2023 · Class II · Z-1073-2024: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patients radiography (RAD) images when starting the next patient scan while the previous patient image export is st
- Dec 15, 2023 · Class II · Z-1072-2024: Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is s
- Sep 21, 2023 · Class II · Z-0280-2024: Potential for units suspended on the ceiling to fail and fall.
- 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
- May 19, 2021 · Class II · Z-1325-2022: Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due t

## 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/K212837
Methodology: https://510kreport.com/methodology