# K163210: Philips CombiDiagnost R90

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Jan 31, 2017 after 77 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 8 (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
- K203087: CombiDiagnost R90 (2020), 1 descendant of its own
- K232910: CombiDiagnost R90 (2023), 0 descendants of its own

## Recalls of this device
- Mar 3, 2023 · Class II · Z-1588-2023: 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
- Feb 11, 2022 · Class II · Z-1087-2024: 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 di
- 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
- Oct 21, 2021 · Class II · Z-1355-2023: 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
- Dec 19, 2019 · Class II · Z-1329-2020: 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 sw
- Dec 19, 2019 · Class II · Z-1328-2020: 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 sw
- Nov 7, 2018 · Class II · Z-0612-2019: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K163210
Methodology: https://510kreport.com/methodology