Cleared Traditional

GOODNET

K010763 · Goodman Co., Ltd. · Radiology
May 2001
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K010763 is an FDA 510(k) clearance for the GOODNET, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Goodman Co., Ltd. (Ridgefield, US). The FDA issued a Cleared decision on May 25, 2001, 72 days after receiving the submission on March 14, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K010763 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2001
Decision Date May 25, 2001
Days to Decision 72 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050

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