Cleared Traditional

K041484 - UNDECIDED (FDA 510(k) Clearance)

K041484 · Siemens Medical Solutions USA, Inc. · Radiology device

Jul 2004

Decision

56d

Days

Class 2

Risk

K041484 is an FDA 510(k) clearance for the UNDECIDED. 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 July 30, 2004, 56 days after receiving the submission on June 4, 2004.

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

Submission Details

510(k) Number	K041484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 04, 2004
Decision Date	July 30, 2004
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF