Skip to content

DigitalDiagnost C50

by Philips Healthcare (Suzhou) Co., Lit.

510(k) K201725

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK201725 Date10 Jul 2020ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1383-2023 FDA Class II initiated 9 Mar 2023
    • Ongoing Z-1382-2023 FDA Class II initiated 9 Mar 2023

    If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through normal wear and tear; as a result there is a potential that the Ceiling Suspension of the DigitalDiagnost C50 system may descend inadvertently if power to the system is interrupted, and may result in injuries to patients and users

    • Ongoing Z-1563-2022 FDA Class II initiated 25 Feb 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 the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DigitalDiagnost C50 is a ceiling mounted digital X-ray system intended for generating radiographic images of human anatomy by qualified doctors or technicians. Applications can be performed with the patient sitting, standing, or lying in various positions.

This system is supplied as a stationary device with a fixed or wireless detector and motorized auto-tracking. It is a Class II device with FDA 510K clearance (K201725) and is regulated under product code KPR. The device is manufactured by Philips Healthcare (Suzhou) Co., Ltd.

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DigitalDiagnost C50 used for?

    The DigitalDiagnost C50 is a ceiling mounted digital X-ray system designed for generating radiographic images of human anatomy by qualified doctors or technicians. It can be used with patients in sitting, standing, or lying positions.

  • How is the DigitalDiagnost C50 supplied?

    This system is supplied as a stationary device with either a fixed or wireless detector option. It includes motorized auto-tracking functionality to assist in positioning during imaging procedures.

  • What is the regulatory status of the DigitalDiagnost C50?

    The DigitalDiagnost C50 is a Class II medical device with FDA 510K clearance (K201725) and is regulated under product code KPR. It was manufactured by Philips Healthcare (Suzhou) Co., Ltd.

  • Can the DigitalDiagnost C50 be used in different clinical settings?

    Yes, the system is versatile enough to accommodate various patient positions including sitting, standing, or lying, making it suitable for different clinical environments and examination types.