Cleared Traditional

K872489 - CENTRALITE
(FDA 510(k) Clearance)

K872489 · Diacor, Inc. · Radiology

Jul 1987

Decision

22d

Days

Class 1

Risk

K872489 is an FDA 510(k) clearance for the CENTRALITE, 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 July 15, 1987, 22 days after receiving the submission on June 23, 1987. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number	K872489 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1987
Decision Date	July 15, 1987
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—