Data / Medical devices / United States / Neosoma, Inc.
Neosoma, Inc.: FDA-registered device maker in Groton, MA, United States, 2 510(k) clearances
Neosoma, Inc. is registered with the FDA (registration 3024812789) in Groton, MA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024812789
- Address
- 44 Farmers Row, Groton, MA, United States, 01450
- Owner or operator
- Neosoma, Inc. (10086388)
- Roles
- Manufacturer
- First device listed
- November 4, 2022
- Registered through
- 2026
- Brand names listed
- Neosoma Brain Mets, Neosoma Glioma
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| Radiological Image Processing Software For Radiation Therapy | QKB | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 17, 2025 | K252922 | Neosoma Brain Mets | QIH | Substantially Equivalent | Neosoma, Inc. | accessdata.fda.gov |
| September 27, 2022 | K221738 | NS-HGlio | QIH | Substantially Equivalent | Neosoma, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of Radiological Image Processing Software For Radiation Therapy
Updated December 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.