510(k) K251037

Device
Rectal Applicator
Applicant
Nucletron B.V.
510(k) number
K251037
Product code
JAQ
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-19
Date received
2025-04-03
Regulation
892.5700
Classification name
System, Applicator, Radionuclide, Remote-Controlled
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Loes Vloet-Emonts
Address
3900 Ax Veenendaal, P.O. Box 930 Waardgelder 1 Veenendaal NL 3905TH 3905TH

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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