Cleared Traditional

NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS

K860472 · Nuclear Diagnostics, Inc. · Radiology
Jul 1986
Decision
147d
Days
Class 1
Risk

About This 510(k) Submission

K860472 is an FDA 510(k) clearance for the NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS, a Monitor, Patient Position, Light-beam (Class I — General Controls, product code IWE), submitted by Nuclear Diagnostics, Inc. (Springfield, US). The FDA issued a Cleared decision on July 3, 1986, 147 days after receiving the submission on February 6, 1986. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5780.

Submission Details

510(k) Number K860472 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1986
Decision Date July 03, 1986
Days to Decision 147 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

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