REGIUS MODEL 210

GUDID 04560141925557

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 04560141925557
• NIH Device Record Key: 5b629e4e-80da-4329-89fc-17a6334ca8bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS MODEL 210
• Version Model Number: A1YD
• 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	04560141925557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092717

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

Devices Manufactured by KONICA MINOLTA, INC.

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• 04560141950788 - G-60: 2023-06-22
• 04560141950795 - G-22: 2023-06-22
• 04560141950849 - KONICAMINOLTA DI-X1: 2023-05-12
• 04560141949287 - P-65: 2022-11-25
• 04560141949294 - P-75: 2022-11-25