Cleared Traditional

K931725 - ALPHA II
(FDA 510(k) Clearance)

K931725 · Dynarad Corp. · Radiology

Jul 1993

Decision

100d

Days

Class 2

Risk

K931725 is an FDA 510(k) clearance for the ALPHA II. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD).

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on July 14, 1993, 100 days after receiving the submission on April 5, 1993.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K931725 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 1993
Decision Date	July 14, 1993
Days to Decision	100 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement