FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmed
DI: 06430035430130
·
Model: XFI
·
Planmed Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmed
- Primary DI
- 06430035430130
- Version / Model
- XFI
- Company Name
- Planmed Oy
- Labeler DUNS
- 459718193
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-21
- Public Version
- 1
- Public Version Date
- 2025-12-01
- Public Version Status
- New
- Public Device Record Key
- c8242bc4-c185-4450-a3c1-60687e906f3b
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| SFV | X-Ray, Computed Tomography, Cone-Beam | Radiology | 892.1750 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37619 | Limited-view-field CT system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035430130 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250318 | 000 |