PLANMED NUANCE EXCEL— 510(k) K111361

Substantially Equivalent

Planmeca USA, Inc.

FDA 510(k) clearance K111361 for PLANMED NUANCE EXCEL, Substantially Equivalent on 2011-09-23. Applicant: Planmeca USA, Inc..

Clearance details

Applicant: Planmeca USA, Inc.
Product code: Code MUE
Advisory panel: Radiology
Date received: 2011-05-16
Decision date: 2011-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

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.