510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K827583Substantially Equivalent

Stereotactic 60 Cobalt Gamma System--Gammaknife

Nucletronix, Inc., Gloucestor MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827583 is the FDA 510(k) clearance record for STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE, a class II device, cleared for Nucletronix, Inc. on under FDA product code IWB (System, Radiation Therapy, Radionuclide). FDA records list one 510(k) clearance for Nucletronix, Inc. As of , FDA records show no recalls naming K827583.

Clearance record

Decision date
Received
(30 days to decision)
Product code
IWB System, Radiation Therapy, Radionuclide
Regulation
21 CFR 892.5750
Device class
Class II
Review panel
Radiology
Applicant
Nucletronix, Inc. Blackburn Center, Gloucestor MA
Third party review
No

Clearances, product code IWB

Trailing 12 months

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

FDA records show no clearances under product code IWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWB, 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