REGIUS MODEL SIGMA2

GUDID 04560141936393

KONICA MINOLTA, INC.

Computed radiography digital imaging scanner

• Primary Device ID: 04560141936393
• NIH Device Record Key: 033c271b-6b60-4c9a-9967-b57d5aa56c1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REGIUS MODEL SIGMA2
• Version Model Number: A5ET
• 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	04560141936393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120131

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 SIGMA2]

• 04560141936423: A5EU
• 04560141936393: A5ET
• 04560141936379: A5ER