Cleared Traditional

K923094 - MOLYBDENUM
(FDA 510(k) Clearance)

K923094 · Southeastern Medical Diagnostics, Inc. · Radiology device

Mar 1993

Decision

252d

Days

Class 1

Risk

K923094 is an FDA 510(k) clearance for the MOLYBDENUM. This device is classified as a Assembly, Tube Housing, X-ray, Diagnostic (Class I - General Controls, product code ITY).

Submitted by Southeastern Medical Diagnostics, Inc. (Greensboro, US). The FDA issued a Cleared decision on March 4, 1993, 252 days after receiving the submission on June 25, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1760.

Submission Details

510(k) Number	K923094 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 25, 1992
Decision Date	March 04, 1993
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement