Cleared Traditional

K983732 - THORAX FD AND MULTIX FD (FDA 510(k) Clearance)

K983732 · Siemens Medical Solutions USA, Inc. · Radiology device

Apr 1999

Decision

181d

Days

Class 2

Risk

K983732 is an FDA 510(k) clearance for the THORAX FD AND MULTIX FD. This device is classified as a Solid State X-ray Imager (flat Panel/digital Imager) (Class II - Special Controls, product code MQB).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 21, 1999, 181 days after receiving the submission on October 22, 1998.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K983732 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 22, 1998
Decision Date	April 21, 1999
Days to Decision	181 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF