Cleared Traditional

K010938 - SYNGO MULTIMODALITY WORKSTATION (FDA 510(k) Clearance)

K010938 · Siemens Medical Solutions USA, Inc. · Radiology device

Jun 2001

Decision

89d

Days

Class 2

Risk

K010938 is an FDA 510(k) clearance for the SYNGO MULTIMODALITY 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 June 26, 2001, 89 days after receiving the submission on March 29, 2001.

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

Submission Details

510(k) Number	K010938 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 2001
Decision Date	June 26, 2001
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF