1 device · 1 company · 2021
Product code QNK: Optoacoustic Imaging System
1 device under product code QNK, 2021, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
Optoacoustic Imaging System. The device is indicated for imaging the breast using optoacoustic technology for breast cancer diagnosis MAUDE held 1 adverse-event report against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Imagio Breast Imaging SystemP200003 · PMA | Seno Medical Instruments, Inc. | Radiology | database entry |
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