Cleared Traditional

K973363 - NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633
(FDA 510(k) Clearance)

K973363 · Ml Strategies, Inc. · Radiology device

Jul 1998

Decision

297d

Days

Class 2

Risk

K973363 is an FDA 510(k) clearance for the NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633. This device is classified as a Source, Isotope, Sealed, Gold, Titanium, Platinum (Class II - Special Controls, product code IWI).

Submitted by Ml Strategies, Inc. (Boston, US). The FDA issued a Cleared decision on July 2, 1998, 297 days after receiving the submission on September 8, 1997.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.

Submission Details

510(k) Number	K973363 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1997
Decision Date	July 02, 1998
Days to Decision	297 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement