SKR 4000

GUDID 04560141948631

KONICA MINOLTA, INC.

Indirect flat panel x-ray detector

• Primary Device ID: 04560141948631
• NIH Device Record Key: 307a65d9-3572-44c0-8b38-2fde4c7b0bc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKR 4000
• Version Model Number: ACX9
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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 Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560141948631 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191645

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

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: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by KONICA MINOLTA, INC.

• 04560141950887 - P-53: 2024-12-16
• 04560141950894 - P-53: 2024-12-16
• 04560141951419 - CS-7: 2024-12-16
• 04560141951433 - Bone Suppression Software: 2024-07-16
• 04560141950399 - ImagePilot: 2023-07-27
• 04560141950771 - G-59: 2023-06-22
• 04560141950788 - G-60: 2023-06-22
• 04560141950795 - G-22: 2023-06-22