# K203087: CombiDiagnost R90

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Dmc GmbH
- Decided: Dec 3, 2020 after 51 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 6 (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)
- K163210: Philips CombiDiagnost R90, Philips Medical Systems Dmc GmbH (2017) Summary page 4.

## Most influential descendants
- K232910: CombiDiagnost R90 (2023), 0 descendants of its own

## Recalls of this device
- Sep 21, 2023 · Class II · Z-0271-2024: Potential for units suspended on the ceiling to fail and fall.
- Mar 3, 2023 · Class II · Z-1589-2023: 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-1088-2024: 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-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
- Sep 22, 2021 · Class II · Z-0241-2022: 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 
- Jul 22, 2020 · Class II · Z-2357-2021: Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This 

## Indications for use
CombiDiagnost R90 1s 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/K203087
Methodology: https://510kreport.com/methodology