MOBILETT Elara Max— 510(k) K182639

Substantially Equivalent

Siemens Medi Cal Solutions, Inc.

FDA 510(k) clearance K182639 for MOBILETT Elara Max, Substantially Equivalent on 2019-03-15. Applicant: Siemens Medi Cal Solutions, Inc..

Clearance details

Applicant: Siemens Medi Cal Solutions, Inc.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2018-09-24
Decision date: 2019-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.