EBM iDO Viewer 1.2.1— 510(k) K162285

Substantially Equivalent

Ebm Technologies Incorporated

FDA 510(k) clearance K162285 for EBM iDO Viewer 1.2.1, Substantially Equivalent on 2017-01-27. Applicant: Ebm Technologies Incorporated.

Clearance details

Applicant: Ebm Technologies Incorporated
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2016-08-15
Decision date: 2017-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.