510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K180515Substantially Equivalent

GammaTile

Isoray Medical, Inc., Richland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180515 is the FDA 510(k) clearance record for GammaTile, a class II device, cleared for Isoray Medical, Inc. on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 5 510(k) clearances for Isoray Medical, Inc., from to . As of , FDA records show no recalls naming K180515.

Clearance record

Decision date
Received
(129 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Isoray Medical, Inc. 350 Hills St., Suite 106, Richland WA
510(k) summary
Summary PDF
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