Cleared Traditional

K030982 - SYNGO COLONOGRAPHY SOFTWARE PACKAGE (FDA 510(k) Clearance)

K030982 · Siemens Medical Solutions USA, Inc. · Radiology device

Apr 2003

Decision

11d

Days

Class 2

Risk

K030982 is an FDA 510(k) clearance for the SYNGO COLONOGRAPHY SOFTWARE PACKAGE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on April 8, 2003, 11 days after receiving the submission on March 28, 2003.

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

Submission Details

510(k) Number	K030982 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2003
Decision Date	April 08, 2003
Days to Decision	11 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF