Beamscan MR— 510(k) K191646

Substantially Equivalent

Ptw-Freiburg Physikalisch-Technische-Werkstaetten

FDA 510(k) clearance K191646 for Beamscan MR, Substantially Equivalent on 2020-02-21. Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten.

Clearance details

Applicant: Ptw-Freiburg Physikalisch-Technische-Werkstaetten
Product code: Code IYE
Advisory panel: Radiology
Date received: 2019-06-20
Decision date: 2020-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freiburg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.