Medical Device Manufacturer · US , Rice Lake , WI

Nucletron B.V. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2013

Recent clearances: Rectal Applicator, Esteya, Geneva

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nucletron B.V. Radiology ✕

11 devices

1-11 of 11

Cleared Dec 19, 2025

Rectal Applicator

Radiology · 260d

Cleared Jan 11, 2022

Radiology · 25d

Cleared Jul 16, 2020

Radiology · 65d

Cleared Jan 27, 2017

Advanced Gynecological Applicator

Radiology · 221d

Cleared Jun 23, 2015

Henschke Titanium Applicator Set

Radiology · 41d

Cleared Mar 10, 2015

Martinez Prostate Template Set

Radiology · 193d

Cleared Jun 26, 2014

Radiology · 87d

Cleared Jun 13, 2014

ONCENTRA BRACHY

Radiology · 277d

Cleared Feb 26, 2014

FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED...

Radiology · 163d

Cleared Feb 21, 2014

LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE...

Radiology · 161d

Cleared Sep 26, 2013

Radiology · 83d