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

Name: FDA 510(k) clearance K013088
Creator: U.S. Food and Drug Administration
Published: 2002-04-04

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.. Device class: 2.

Clearance details

Applicant: Echotech 3D Imaging Systems, Inc.
Product code: Code IYO
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2001-09-17
Decision date: 2002-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Hills, CO, US

Download summary PDF View on FDA.gov ↗

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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.