Cleared Abbreviated

CYPRESS SYSTEM

K010950 · Acuson Corp. · Radiology
Jun 2001
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K010950 is an FDA 510(k) clearance for the CYPRESS SYSTEM, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Acuson Corp. (Washington, US). The FDA issued a Cleared decision on June 27, 2001, 90 days after receiving the submission on March 29, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K010950 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2001
Decision Date June 27, 2001
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF

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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