510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K013088Substantially Equivalent

Echotech Easy 3D Family, Echotech 3D Freescan, Echotech Easyarchive, Echotech Quanticon, Echotech Easystress

Echotech 3D Imaging Systems GmbH, Indian Hills CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013088 is the FDA 510(k) clearance record for ECHOTECH EASY 3D FAMILY, ECHOTECH 3D FREESCAN, ECHOTECH EASYARCHIVE, ECHOTECH QUANTICON, ECHOTECH EASYSTRESS, a class II device, cleared for Echotech 3D Imaging Systems, Inc. on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 2 510(k) clearances for Echotech 3D Imaging Systems, Inc., from to . As of , FDA records show no recalls naming K013088.

Clearance record

Decision date
Received
(199 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Echotech 3D Imaging Systems, Inc. P.O. Box 218, Indian Hills CO
510(k) summary
Summary
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260