Planmeca Viso 30048120, 30035196, 30016794, 30054720, 30064043,

GUDID 06430035420988

The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillofacial and ENT anatomies. Two dimensional (2D) images are produced with tomosynthesis method (panoramic imaging) as well as conventional 2D radiography (cephalometric imaging, 2D views). In CBCT a cylindrical volume of data is captured in one imaging procedure. The data consists of several hundred sample images which are taken from different directions to cover a certain pre-programmed target area. These samples are used for 3D reconstruction (using a separate 3D reconstruction PC) that can be viewed in three dimensions using separate workstation and Planmeca Romexis software.

Planmeca Oy

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 06430035420988
• NIH Device Record Key: a0b191fc-31f2-4a7d-9b0b-a94d7aa4e105
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca Viso
• Version Model Number: G5 (G3)
• Catalog Number: 30048120, 30035196, 30016794, 30054720, 30064043,
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420605 [Previous]
GS1	06430035420988 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230985

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-09-15
• Device Publish Date: 2024-01-10

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
• 06430035420995: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi
• 06430035420988: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensi