Search Results
Found 3 results
510(k) Data Aggregation
K Number
K201272Device Name
Geneva
Manufacturer
Nucletron BV
Date Cleared
2020-07-16
(65 days)
Product Code
JAQ, GEN, JAO
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
Nucletron BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for intracavitary for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial brachytherapy.
Device Description
The Geneva is a gynecological applicator for intracavitary brachytherapy with the option for interstitial brachytherapy treatment. It can be used for the treatment of the cervix and endometrium. The applicator consists of tubes and ovoids, guiding the radioactive source of the afterloader to the target volume. Compatible components can be combined to reach a wide range of target areas.
Ask a Question
K Number
K161688Device Name
Advanced Gynecological Applicator
Manufacturer
NUCLETRON BV
Date Cleared
2017-01-27
(221 days)
Product Code
JAQ
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
NUCLETRON BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Advanced Gynecological Applicator is intracavitary for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.
Device Description
The Advanced Gynecological Applicator is a gynecological applicator for intracavitary and interstitial brachytherapy treatment. It can be used it for treatment of the vagina, cervix and uterus. The applicator consists of tubes, caps and templates to place needles. Components can be combined to reach a wide range of target areas. The tubes and the needles, if used, guide the radioactive source of the afterloader to the target volume.
Ask a Question
K Number
K142439Device Name
Martinez Prostate Template Set
Manufacturer
Nucletron BV
Date Cleared
2015-03-10
(193 days)
Product Code
JAQ
Regulation Number
892.5700Why did this record match?
Applicant Name (Manufacturer) :
Nucletron BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The maximum application duration per treatment application is 28 days.
Device Description
Not Found
Ask a Question
Page 1 of 1