Atlas FDA

SFV

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
X-Ray, Computed Tomography, Cone-Beam
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Medical specialty
Radiology
FDA definition
Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Planmed XFI (K250318)Planmed OY2025-09-26

Track SFV automatically

Every clearance here is in the API, with alerts when new ones post.