Cleared Traditional

K000052 - X-RAY MONOBLOCK, MONOBLOCK XRS-60-330
(FDA 510(k) Clearance)

K000052 · Dynarad Corp. · Radiology

Feb 2000

Decision

34d

Days

Class 1

Risk

K000052 is an FDA 510(k) clearance for the X-RAY MONOBLOCK, MONOBLOCK XRS-60-330, a Assembly, Tube Housing, X-ray, Diagnostic (Class I — General Controls, product code ITY), submitted by Dynarad Corp. (Deer Park, US). The FDA issued a Cleared decision on February 10, 2000, 34 days after receiving the submission on January 7, 2000. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1760.

Submission Details

510(k) Number	K000052 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2000
Decision Date	February 10, 2000
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement