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KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography

by Konica Minolta Healthcare Americas, Inc 510(k)

Active United States

510(k) K193225

Overview

The KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography and KDR AU System Advanced U-Arm with Static Digital Radiography is a digital radiography system designed for efficient workflow and exceptional dose management, featuring both dynamic and static imaging capabilities. It is a stationary X-ray system that supports detailed bone and soft tissue visualization through state-of-the-art imaging software.

The system is intended for use by qualified personnel in various medical settings. It is supplied as a complete system and is regulated under FDA 510(k) clearance with device class 2. The system includes multiple components with specific registration numbers and is manufactured by Konica Minolta Healthcare Americas, Inc.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK193225 Date15 Jan 2020ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KPR
FDA applicant
Konica Minolta Healthcare Americas, Inc.
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the KDR AU-DDR System used for?

    The KDR AU-DDR System is a stationary X-ray system designed for detailed bone and soft tissue visualization through state-of-the-art imaging software, intended for use by qualified personnel in various medical settings.

  • How is the KDR AU-DDR System supplied?

    The system is supplied as a complete system with multiple components, each having specific registration numbers, and is manufactured by Konica Minolta Healthcare Americas, Inc.

  • What regulatory status does the KDR AU-DDR System have?

    The system is regulated under FDA 510(k) clearance with device class 2 and has been determined to be substantially equivalent to predicate devices.

  • What imaging capabilities does the KDR AU-DDR System offer?

    The system offers both dynamic and static imaging capabilities, designed for efficient workflow and exceptional dose management through state-of-the-art imaging software.