Product code QNK

Device name

Optoacoustic Imaging System

Medical specialty

Unknown

Device class

3

Review panel

RA

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis

Source

FDA openFDA device classification dataset