VisionX

GUDID E247E7300

Dental Imaging Software. Software Version 2.x.x.

DÜRR DENTAL SE

General-purpose dental x-ray system application software

• Primary Device ID: E247E7300
• NIH Device Record Key: eee7dab1-6af1-4f1a-bcd9-ba151fbd1269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisionX
• Version Model Number: E7300
• Company DUNS: 315563684
• Company Name: DÜRR DENTAL SE
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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
HIBCC	E247E7300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192743

FDA Product Code

• LLZ: System, Image Processing, Radiological
• QIH: Automated Radiological Image Processing Software

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: 2019-12-13
• Device Publish Date: 2019-12-05

On-Brand Devices [VisionX]

• E247E7300: Dental Imaging Software. Software Version 2.x.x.
• E247E7300A10: VisionX version 3.0.x