510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973363Substantially Equivalent

North American Scientific(nasi)pd-103 Radionuclide Brachytherapy Source-Model Med3633

Ml Strategies, Inc., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973363 is the FDA 510(k) clearance record for NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633, a class II device, cleared for Ml Strategies, Inc. on under FDA product code IWI (Source, Isotope, Sealed, Gold, Titanium, Platinum). FDA records list 4 510(k) clearances for Ml Strategies, Inc., from to . As of , FDA records show no recalls naming K973363.

Clearance record

Decision date
Received
(297 days to decision)
Product code
IWI Source, Isotope, Sealed, Gold, Titanium, Platinum
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Ml Strategies, Inc. One Financial Center, Boston MA
510(k) summary
Statement
Third party review
No

Clearances, product code IWI

Trailing 12 months

FDA records hold no clearances under product code IWI in the trailing twelve months.

FDA records show no clearances under product code IWI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260