Planmeca Viso 30016183

GUDID 06430035420605

The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomie

Planmeca Oy

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 06430035420605
• NIH Device Record Key: fdab0eba-a152-48e7-86cd-4e9cbd7c934d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca Viso
• Version Model Number: G5
• Catalog Number: 30016183
• Company DUNS: 368788568
• Company Name: Planmeca 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181576

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2019-03-14
• Device Publish Date: 2019-03-06

On-Brand Devices [Planmeca Viso]

• 06430035420605: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi
• 06430035420551: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi