Ml Strategies, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Ml Strategies, Inc. makes
Ml Strategies, Inc. manufactures diagnostic and therapeutic medical devices, including a web-based radiation treatment planning system (FRAMEWAVE WEB), radionuclide brachytherapy sources for prostate cancer treatment (NASI PD-103 and I-125 models), and a pregnancy detection test system (HCG test system).
The company’s portfolio consists of Class II devices, all of which are authorised via the FDA’s 510(k) clearance process. These products are listed under the US regulatory framework and are based in the United States.
Catalogue
Framewave Web Ref K983401
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-A Ref K972271
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ml Strategies, Inc. have in the registry?
The registry currently lists 4 devices for Ml Strategies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ml Strategies, Inc.'s devices?
Among its 4 most recently registered devices, Ml Strategies, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Ml Strategies, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Ml Strategies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ml Strategies, Inc. in the registry?
The most recently registered devices listed for Ml Strategies, Inc. include FRAMEWAVE WEB, NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED3633, HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM FOR THE EARLY DETECTION OF PREGNANCY and NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A.