Cleared Traditional

K071287 - ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO
(FDA 510(k) Clearance)

K071287 · Shimadzu Medical Systems · Radiology

Jan 2008

Decision

246d

Days

Class 2

Risk

K071287 is an FDA 510(k) clearance for the ECHOVIEW / SHIMASONIC DIAGNOSTIC ULTRASOUND DEVICE, MODEL SDU-2200PRO. This device is classified as a Transducer, Ultrasonic, Diagnostic (Class II — Special Controls, product code ITX).

Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on January 9, 2008, 246 days after receiving the submission on May 8, 2007.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K071287 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2007
Decision Date	January 09, 2008
Days to Decision	246 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF