Brainance MD— 510(k) K202808

Substantially Equivalent

Advantis Medical Imaging Single Member P.C.

FDA 510(k) clearance K202808 for Brainance MD, Substantially Equivalent on 2021-10-14. Applicant: Advantis Medical Imaging Single Member P.C..

Clearance details

Applicant: Advantis Medical Imaging Single Member P.C.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-09-23
Decision date: 2021-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athens, GR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.