Planmeca Viso - The Planmeca Viso -X-ray unit uses cone beam - Planmeca Oy

Duns Number:368788568

Device Description: The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-d 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.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

30004941

Brand Name

Planmeca Viso

Version/Model Number

G7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K181576

Product Code Details

Product Code

OAS

Product Code Name

X-Ray, Tomography, Computed, Dental

Device Record Status

Public Device Record Key

f59dcbd9-2097-469b-95c6-c5f6a79a3157

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PLANMECA OY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 20