KDR DDR Primary U Arm

GUDID 00817100021268

KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography (Primary U-Arm Kit)

KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 00817100021268
• NIH Device Record Key: 079196fe-4752-4d3a-9ab0-11e900cbb1ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KDR DDR Primary U Arm
• Version Model Number: Primary
• Company DUNS: 080269345
• Company Name: KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817100021268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193225

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.

• 00817100021268 - KDR DDR Primary U Arm: 2025-08-07KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography (Primary U-Arm Kit)
• 00817100021268 - KDR DDR Primary U Arm: 2025-08-07 KDR AU-DDR System Advanced U-Arm With Dynamic Digital Radiography (Primary U-Arm Kit)
• 00817100020254 - 14X17 Wireless GOS Flat Panel Detector: 2019-05-07 IR 14X17 Wireless GOS Flat Panel Detector -R or -L)
• 00817100020315 - RF 14X17 Sensor Panel: 2019-05-07 RF 14X17 Sensor Panel-R
• 00817100020483 - RF 11X14 Sensor Panel: 2019-05-07 RF 11X14 Sensor Panel -R/-L
• 00817100020513 - RF 11X14 Sensor Panel: 2019-05-07 DR-PANEL-LT1114-L / R
• 00817100020193 - Konica Minolta SW (PACS) Exa: 2019-02-21 EXA is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound s
• 00817100020209 - Konica Minolta SW (PACS) Opal Rad, 20/20 Opal Rad: 2019-02-21 Opal-RAD is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultraso
• 00817100020216 - 17X17 CsI Fixed Flat Panel Detector: 2019-02-21 IR 17X17 CsI Fixed Flat Panel Detector (-R or -L)