510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QNKClass III

Optoacoustic Imaging System

Unknown
FDA source (opens on fda.gov)

QNK is the FDA product code for Optoacoustic Imaging System, a class III device type. FDA's definition for this code reads: "The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
QNK
Device name
Optoacoustic Imaging System
FDA definition
The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code