# Ml Strategies, Inc.

- Location (FDA's records): Boston, MA
- FDA decisions: 4 (1995–1998): 4 510(k) clearances
- Product codes: IWI (1), KXK (1), LLZ (1), LCX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- International Isotopes, Inc.: 2 (https://510kreport.com/company/international-isotopes)
- Uromed Corp.: 1 (https://510kreport.com/company/uromed)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)
- Implant Sciences Corp.: 1 (https://510kreport.com/company/implant-sciences)

## Its most-cited devices
- K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a (1997), cited by 5

## Recent decisions
- K983401: Framewave Web (Dec 15, 1998)
- K973363: North American Scientific (Nasi)PD-103 Radionuclide Brachytherapy Source-Model MED3633 (Jul 2, 1998)
- K972271: North American Scientific (Nasi) I-125 Radionuclide Brachytherapy Source- Model Med 3631-a (Oct 28, 1997)
- K950354: Human Chorionic Gonadotropin (HCG) Test System for the Early Detection of Pregnancy (Jul 19, 1995)

Source page: https://510kreport.com/company/ml-strategies