Planmed

Primary DI
06430035430130
Brand
Planmed
Company
Planmed Oy
Model
XFI
Device description
The Planmed XFI X-ray unit utilizes cone beam computed tomography (CBCT) to generate three dimensional images. In CBCT imaging, a cylindrical volume of data is acquired in a single imaging procedure. This data comprises several hundred 2D images taken from various angles to encompass a specific pre-programmed target area. These images are subsequently employed for 3D reconstruction, accomplished through a dedicated PC equipped with reconstruction algorithms. The resulting reconstructed images can be visualized in three dimensions using a separate PC workstation equipped with suitable image viewer software.
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SFVX-Ray, Computed Tomography, Cone-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFVX-Ray, Computed Tomography, Cone-BeamRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250318000Planmed XFIPlanmed OY2025-09-26SFV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06430035430130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06430035430130064300354301306430035430130

GMDN Terms#

Term, Definition table
TermDefinition
Limited-view-field CT systemAn assembly of diagnostic x-ray computed tomography (CT) devices having a gantry whose design limits its use to head and neck and/or extremity imaging applications. Included are single or multiple fixed annular arrays of x-ray tubes and opposing detectors or x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.

Regulatory Flags#

DUNS number
459718193
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06430035430024PlanmedNuance Excel2016-09-08
06430035430055PlanmedSophie Classic2016-09-07
06430035430062Planmed Verity2016-09-07
06430035430079PlanmedClarity2018-11-26