Cleared Traditional

K932354 - 9170, 1170
(FDA 510(k) Clearance)

K932354 · Dynarad Corp. · Radiology

Jul 1993

Decision

71d

Days

Class 2

Risk

K932354 is an FDA 510(k) clearance for the 9170, 1170. This device is classified as a System, X-ray, Mobile (Class II — Special Controls, product code IZL).

Submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on July 23, 1993, 71 days after receiving the submission on May 13, 1993.

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

Submission Details

510(k) Number	K932354 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 13, 1993
Decision Date	July 23, 1993
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement