REGIUS MODEL 110

GUDID 04560141936706

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 04560141936706
• NIH Device Record Key: 35f3aa98-8aa4-4f28-8f5e-7d7a5f6c62fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS MODEL 110
• Version Model Number: A5RE
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	04560141936706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071181

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: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-09-19

On-Brand Devices [REGIUS MODEL 110]

• 04560141936706: A5RE
• 04560141936690: A5RD
• 04560141921788: JFF7