Product code SHN

Device name

Calibration Software For Radiology Displays

Medical specialty

Radiology

Device class

1

Regulation number

892.1940

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The software is intended to calibrate displays to meet quality criteria that enable their use in primary diagnostic radiology.

Source

FDA openFDA device classification dataset