Cleared Traditional

K981217 - PLATINUM READING, REVIEW & ANALYSIS WORKSTATION (FDA 510(k) Clearance)

K981217 · GE Medical Systems · Radiology device

Jun 1998

Decision

76d

Days

Class 2

Risk

K981217 is an FDA 510(k) clearance for the PLATINUM READING, REVIEW & ANALYSIS WORKSTATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by GE Medical Systems (Waukesha, US). The FDA issued a Cleared decision on June 18, 1998, 76 days after receiving the submission on April 3, 1998.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K981217 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 03, 1998
Decision Date	June 18, 1998
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF