DIGORA Optime 900267

GUDID 06430035872473

PaloDEx Group Oy

Radiography digital imaging scanner

• Primary Device ID: 06430035872473
• NIH Device Record Key: a34d07b8-ce94-4790-9afc-679e736509ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGORA Optime
• Version Model Number: DXR50
• Catalog Number: 900267
• Company DUNS: 459955188
• Company Name: PaloDEx Group Oy
• 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

Customer Support Contacts

• Phone: 8005586120
• Email: kkg.imaging@kavokerrgroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035872473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041050

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: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2016-08-31

On-Brand Devices [DIGORA Optime]

• 06430035872480: DXR60
• 06430035872473: DXR50