Medical Device Manufacturer · US , Rice Lake , WI

Nucletron B.V.

11 submissions · 11 cleared · Since 2013
11
Total
11
Cleared
0
Denied

Nucletron B.V. — FDA 510(k) Submissions

Nucletron B.V. has submitted 11 FDA 510(k) premarket notifications since 2013, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Applicator, Radionuclide, Remote-controlled, System, Therapeutic, X-ray, System, Planning, Radiation Therapy Treatment . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Rectal Applicator
K251037 · JAQ System, Applicator,... · Radiology
Dec 2025 260d
Esteya
K213942 · JAD System, Therapeutic, X-ray · Radiology
Jan 2022 25d
Geneva
K201272 · JAQ System, Applicator,... · Radiology
Jul 2020 65d
Advanced Gynecological Applicator
K161688 · JAQ System, Applicator,... · Radiology
Jan 2017 221d
Henschke Titanium Applicator Set
K151272 · JAQ System, Applicator,... · Radiology
Jun 2015 41d
Martinez Prostate Template Set
K142439 · JAQ System, Applicator,... · Radiology
Mar 2015 193d
LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
K140803 · JAQ System, Applicator,... · Radiology
Jun 2014 87d
ONCENTRA BRACHY
K132816 · MUJ System, Planning,... · Radiology
Jun 2014 277d
FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 MM)
K132889 · JAQ System, Applicator,... · Radiology
Feb 2014 163d
LUMENCARE AZURE SET F6, 150CM, LUMECARE AZURE SET 5F, 150 CM, LUMENCARE AZURE SET 5F, 140 CM
K132874 · JAQ System, Applicator,... · Radiology
Feb 2014 161d
ESTEYA
K132092 · JAD System, Therapeutic, X-ray · Radiology
Sep 2013 83d
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