Cleared Traditional

CENTRALITE BACKPOINTER

K954414 · Diacor, Inc. · Radiology
Oct 1995
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K954414 is an FDA 510(k) clearance for the CENTRALITE BACKPOINTER, 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 October 23, 1995, 32 days after receiving the submission on September 21, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K954414 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1995
Decision Date October 23, 1995
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IWE — Monitor, Patient Position, Light-beam
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5780