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FDA 510(k)

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS

K-Number: K013088 · 2002-04-04

ApplicantEchotech 3D Imaging Systems, Inc.
Decision Date2002-04-04
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS is the device name listed in this FDA 510(k) record. The listed applicant is Echotech 3D Imaging Systems, Inc.. It received FDA 510(k) clearance on 2002-04-04 under 510(k) number K013088. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS?

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS is a medical device that received FDA 510(k) clearance on 2002-04-04. The listed applicant is Echotech 3D Imaging Systems, Inc.. The 510(k) number is K013088.

When did ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS receive FDA 510(k) clearance?

ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS received FDA 510(k) clearance on 2002-04-04, under 510(k) number K013088.

Who is the listed applicant for ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS?

The FDA 510(k) record lists Echotech 3D Imaging Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS?

The FDA product code for ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS is IYO.

Related Clinical Trials

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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