Cleared Traditional

K955185 - GE ADVANTAGE DICOM CR REPROCESSING STATION (FDA 510(k) Clearance)

K955185 · GE Medical Systems · Radiology device

Jan 1996

Decision

51d

Days

Class 2

Risk

K955185 is an FDA 510(k) clearance for the GE ADVANTAGE DICOM CR REPROCESSING STATION. 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 January 3, 1996, 51 days after receiving the submission on November 13, 1995.

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

Submission Details

510(k) Number	K955185 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 13, 1995
Decision Date	January 03, 1996
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF