ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS— 510(k) K013088

Substantially Equivalent

Echotech 3D Imaging Systems, Inc.

FDA 510(k) clearance K013088 for ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS, Substantially Equivalent on 2002-04-04. Applicant: Echotech 3D Imaging Systems, Inc..

Clearance details

Applicant: Echotech 3D Imaging Systems, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2001-09-17
Decision date: 2002-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Hills, CO, US

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.