Product code SFV

Device name

X-Ray, Computed Tomography, Cone-Beam

Medical specialty

Radiology

Device class

2

Regulation number

892.1750

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Cone-beam computed tomography produced cross-sectional diagnostic x-ray images of whole body except dental structures.

Source

FDA openFDA device classification dataset