Cleared Traditional

K973833 - CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL
(FDA 510(k) Clearance)

K973833 · Dynarad Corp. · Radiology

Dec 1997

Decision

84d

Days

Class 2

Risk

K973833 is an FDA 510(k) clearance for the CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY, TUBE HOUSING DIAGNOSTIC, BEAM LIMITING DEVICE, MANUAL, 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 December 30, 1997, 84 days after receiving the submission on October 7, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1720.

Submission Details

510(k) Number	K973833 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 07, 1997
Decision Date	December 30, 1997
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement