Cleared Traditional

K883359 - DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A
(FDA 510(k) Clearance)

Jan 1989
Decision
168d
Days
Class 2
Risk

K883359 is an FDA 510(k) clearance for the DIAGNOSTIC ULTRASOUND SYSTEM SSA-270A. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).

Submitted by Toshiba Medical Systems (Tustin, US). The FDA issued a Cleared decision on January 25, 1989, 168 days after receiving the submission on August 10, 1988.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K883359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1988
Decision Date January 25, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II - Special Controls
CFR Regulation 21 CFR 892.1560

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