510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003206Substantially Equivalent

Gliasite Radiation Therapy System (Rts), Model 1020,1030,1040,8150,9005

Proxima Therapeutics, Inc., Alpharetta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003206 is the FDA 510(k) clearance record for GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005, a class II device, cleared for Proxima Therapeutics, Inc. on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 5 510(k) clearances for Proxima Therapeutics, Inc., from to . As of , FDA records show no recalls naming K003206.

Clearance record

Decision date
Received
(194 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Proxima Therapeutics, Inc. 2555 Marconi Dr., Suite 220, Alpharetta GA
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