Nucletron B.V. - FDA 510(k) Cleared Devices
Recent clearances: Rectal Applicator, Esteya, Geneva
12
Total
12
Cleared
0
Denied
FDA 510(k) Regulatory Record - Nucletron B.V. Radiology ✕
12 devices
Cleared
Jul 24, 2026
LumenCare Azure
Radiology
11d
Cleared
Dec 19, 2025
Rectal Applicator
Radiology
260d
Cleared
Jan 11, 2022
Esteya
Radiology
25d
Cleared
Jul 16, 2020
Geneva
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
LUNERAY
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
ESTEYA
Radiology
83d