Biolucent, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Biolucent, Inc. makes
Biolucent, Inc. manufactures customizable seed arrays for brachytherapy, including the CURAY CUSTOM SEED ARRAY, and radiolucent mammography cushions like the BIOLUCENT MAMMOGRAPHY CUSHION and MAMMOPAD RADIOLUCENT CUSHION. The company also produces applicator kits and applicators, such as the BIOLUCENT APPLICATOR KIT and the BIOLUCENT APPLICATOR (Model RTA-XX), designed for targeted radiation therapy procedures.
The company’s devices are classified under FDA’s Class I and Class II categories, with relevant products authorised via the 510(k) pathway. These products are registered with the FDA’s regulatory system in the United States, where Biolucent, Inc. is based.
Catalogue
Curay Custom Seed Array Ref K053595
Regimes: 510(k) Registry: 510(k)Biolucent Mammography Cushion Ref K003795
Regimes: 510(k) Registry: 510(k)Biolucent Applicator Kit Ref K070659
Regimes: 510(k) Registry: 510(k)Biolucent Applicator Kit Ref K062830
Regimes: 510(k) Registry: 510(k)Biolucent Applicator, Model Rta-Xx Ref K061241
Regimes: 510(k) Registry: 510(k)Mammopad Radiolucent Cushion Ref K062141
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Biolucent, Inc. have in the registry?
The registry currently lists 6 devices for Biolucent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biolucent, Inc.'s devices?
Among its 6 most recently registered devices, Biolucent, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Biolucent, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Biolucent, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biolucent, Inc. in the registry?
The most recently registered devices listed for Biolucent, Inc. include CURAY CUSTOM SEED ARRAY, BIOLUCENT MAMMOGRAPHY CUSHION, BIOLUCENT APPLICATOR KIT and BIOLUCENT APPLICATOR, MODEL RTA-XX.