Cleared Special

K023190 - E.CAM COMPUTER / E.SOFT WORKSTATION (FDA 510(k) Clearance)

K023190 · Siemens Medical Solutions USA, Inc. · Radiology device

Oct 2002

Decision

29d

Days

Class 2

Risk

K023190 is an FDA 510(k) clearance for the E.CAM COMPUTER / E.SOFT 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. (Hoffman Estates, US). The FDA issued a Cleared decision on October 24, 2002, 29 days after receiving the submission on September 25, 2002.

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

Submission Details

510(k) Number	K023190 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 25, 2002
Decision Date	October 24, 2002
Days to Decision	29 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF