NEOSOMA, INC.

FDA Device Registration & Listing · Groton, MA, US · Registration 3024812789

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3024812789
FEI Number
3024812789
Entity Name
NEOSOMA, INC.
City/State/Country
Groton, MA, US
Establishment Address
44 Farmers Row, Groton, MA 01450, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Neosoma, Inc. (Owner Number: 10086388)
Owner / Operator Contact Address
44 Farmers Row, Groton, MA 01450, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252922
PMA Number
N/A

All Registered Proprietary Names

Neosoma Glioma Neosoma Brain Mets

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2022-11-04
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-02-03
QKB Radiological Image Processing Software For Radiation Therapy Radiology Class 2 892.2050 2026-02-03

Official Correspondent

Ken Kolodziej

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neosoma, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024812789. Last updated year: 2026. Please use registration number 3024812789 when referencing this establishment in official correspondence.
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