Cleared Traditional

K973638 - N.I.T., INC. NEEDLE GUIDING TEMPLATE
(FDA 510(k) Clearance)

K973638 · Avid N.I.T., Inc. · Radiology

Dec 1997

Decision

90d

Days

Class 1

Risk

K973638 is an FDA 510(k) clearance for the N.I.T., INC. NEEDLE GUIDING TEMPLATE. This device is classified as a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ).

Submitted by Avid N.I.T., Inc. (Oldsmar, US). The FDA issued a Cleared decision on December 23, 1997, 90 days after receiving the submission on September 24, 1997.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number	K973638 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 1997
Decision Date	December 23, 1997
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement