Cleared Traditional

CENTRALITE(R)-DLL SERIES

K950112 · Diacor, Inc. · Radiology

Aug 1995

Decision

217d

Days

Class 1

Risk

About This 510(k) Submission

K950112 is an FDA 510(k) clearance for the CENTRALITE(R)-DLL SERIES, a Monitor, Patient Position, Light-beam (Class I — General Controls, product code IWE), submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 16, 1995, 217 days after receiving the submission on January 11, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number	K950112 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 11, 1995
Decision Date	August 16, 1995
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF