Cleared Traditional

N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000

K973037 · Avid N.I.T., Inc. · Radiology
Jan 1998
Decision
166d
Days
Class 1
Risk

About This 510(k) Submission

K973037 is an FDA 510(k) clearance for the N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000, 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 January 27, 1998, 166 days after receiving the submission on August 14, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5650.

Submission Details

510(k) Number K973037 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1997
Decision Date January 27, 1998
Days to Decision 166 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IWJ — System, Applicator, Radionuclide, Manual
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.5650

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