Cleared Traditional

VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION

K952313 · Varian Assoc., Inc. · Radiology

Aug 1995

Decision

91d

Days

Class 2

Risk

About This 510(k) Submission

K952313 is an FDA 510(k) clearance for the VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 16, 1995, 91 days after receiving the submission on May 17, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K952313 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 1995
Decision Date	August 16, 1995
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF