Cleared Traditional

K932106 - MOBILETT PLUS MOBILE X-RAY SYSTEM (FDA 510(k) Clearance)

K932106 · Siemens Medical Solutions USA, Inc. · Radiology device

Sep 1994

Decision

499d

Days

Class 2

Risk

K932106 is an FDA 510(k) clearance for the MOBILETT PLUS MOBILE X-RAY SYSTEM. This device is classified as a System, X-ray, Mobile (Class II - Special Controls, product code IZL).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 14, 1994, 499 days after receiving the submission on May 3, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K932106 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 03, 1993
Decision Date	September 14, 1994
Days to Decision	499 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF