Cleared Traditional

K972554 - REGANES RADIONUCLIDE SEED MAGAZINE
(FDA 510(k) Clearance)

K972554 · Avid N.I.T., Inc. · Radiology

Feb 1998

Decision

224d

Days

Class 1

Risk

K972554 is an FDA 510(k) clearance for the REGANES RADIONUCLIDE SEED MAGAZINE. This device is classified as a System, Applicator, Radionuclide, Manual (Class I — General Controls, product code IWJ).

Submitted by Avid N.I.T., Inc. (Tarpon Springs, US). The FDA issued a Cleared decision on February 17, 1998, 224 days after receiving the submission on July 8, 1997.

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

Submission Details

510(k) Number	K972554 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1997
Decision Date	February 17, 1998
Days to Decision	224 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement