Cleared Traditional

K973010 - REALTIME 3D DIAGNOSTIC WORKSTATION (FDA 510(k) Clearance)

K973010 · Siemens Medical Solutions USA, Inc. · Radiology device

Nov 1997

Decision

89d

Days

Class 2

Risk

K973010 is an FDA 510(k) clearance for the REALTIME 3D DIAGNOSTIC WORKSTATION. 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 November 10, 1997, 89 days after receiving the submission on August 13, 1997.

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

Submission Details

510(k) Number	K973010 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 13, 1997
Decision Date	November 10, 1997
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF