Product code PGY

Device name

Display, Diagnostic Radiology

Medical specialty

Radiology

Device class

2

Regulation number

892.2050

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

Definition

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

Source

FDA openFDA device classification dataset