Cleared Traditional

3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING

K002807 · Acuson Corp. · Radiology
Dec 2000
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K002807 is an FDA 510(k) clearance for the 3D ORGAN ASSESSMENT W/ MAGNETIC POSITION SENSING, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Acuson Corp. (Mountain View, US). The FDA issued a Cleared decision on December 1, 2000, 84 days after receiving the submission on September 8, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K002807 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 2000
Decision Date December 01, 2000
Days to Decision 84 days
Submission Type Traditional
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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