Planmed Clarity— 510(k) K163328

Substantially Equivalent

Planmed OY

FDA 510(k) clearance K163328 for Planmed Clarity, Substantially Equivalent on 2017-12-28. Applicant: Planmed OY.

Clearance details

Applicant: Planmed OY
Product code: Code MUE
Advisory panel: Radiology
Date received: 2016-11-28
Decision date: 2017-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Helsinki, FI

Download summary PDF View on FDA.gov ↗

Adverse events under product code MUE

product code MUE

Death: 5
Other: 1
Total: 6

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.