Cleared Traditional

K935694 - SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE (FDA 510(k) Clearance)

K935694 · Siemens Medical Solutions USA, Inc. · Radiology device

Mar 1994

Decision

98d

Days

Class 2

Risk

K935694 is an FDA 510(k) clearance for the SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 7, 1994, 98 days after receiving the submission on November 29, 1993.

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

Submission Details

510(k) Number	K935694 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 29, 1993
Decision Date	March 07, 1994
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF