MOBILEDIAGNOST WDR— 510(k) K141895

Substantially Equivalent

Sedecal., Sa.

FDA 510(k) clearance K141895 for MOBILEDIAGNOST WDR, Substantially Equivalent on 2014-09-18. Applicant: Sedecal., Sa..

Clearance details

Applicant: Sedecal., Sa.
Product code: Code IZL
Advisory panel: Radiology
Date received: 2014-07-14
Decision date: 2014-09-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Seneca, SC, 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.