Isoaid, LLC
United StatesFDA applicant, unverified
- Devices
- 6
What Isoaid, LLC makes
Isoaid, LLC manufactures brachytherapy devices, including radioactive seed localization needles (I-125 RSLN), brachytherapy kits (ADVANTAGE-STRAND and ADVANTAGE-LOAD), and a radioactive seed delivery system (IsoSphere). These products are designed for targeted radiation therapy in medical procedures, such as prostate interventions.
The company’s portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) pathway. These devices are regulated under U.S. federal standards and are intended for commercial distribution within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Isoaid Advantage Pd-103, Model Iapd-103A Ref K033770
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
IsoSphere Ref K242818
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Isoaid, LLC have in the registry?
The registry currently lists 6 devices for Isoaid, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Isoaid, LLC's devices?
Among its 6 most recently registered devices, Isoaid, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Isoaid, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Isoaid, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Isoaid, LLC in the registry?
The most recently registered devices listed for Isoaid, LLC include I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE], ISOAID ADVANTAGE PD-103, MODEL IAPD-103A, ADVANTAGE-STRAND/ ADVANTAGE-LOAD BRACHYTHERAPY KIT, MODEL IASLBKA and ISOAID IODINE BRACHTHERAPY SEEDS, MODEL ADVANTAGE I-125.