510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000475Substantially Equivalent

Brachyseed

Draximage, Inc., Kirkland, Qc, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000475 is the FDA 510(k) clearance record for BRACHYSEED, a class II device, cleared for Draximage, Inc. on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 2 510(k) clearances for Draximage, Inc., from to . As of , FDA records show no recalls naming K000475.

Clearance record

Decision date
Received
(189 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Draximage, Inc. 16751 Trans Canada Hwy., Kirkland, Qc, CA
510(k) summary
Summary
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260