Cleared Traditional

K960146 - G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY
(FDA 510(k) Clearance)

K960146 · GE Medical Systems · Radiology

Feb 1996

Decision

42d

Days

Class 2

Risk

K960146 is an FDA 510(k) clearance for the G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY, a System, X-ray, Photofluorographic (Class II — Special Controls, product code IZG), submitted by GE Medical Systems (Palm Harbor, US). The FDA issued a Cleared decision on February 27, 1996, 42 days after receiving the submission on January 16, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1730.

Submission Details

510(k) Number	K960146 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 1996
Decision Date	February 27, 1996
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement