FDA.reportPublic FDA data

Neosoma Brain Mets

Primary DI
00860009223660
Brand
Neosoma Brain Mets
Company
Neosoma, Inc.
Model
1
Published
2026-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIHAutomated Radiological Image Processing SoftwareRadiology2
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252922000Neosoma Brain MetsNeosoma, Inc.2025-12-17QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009223660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009223660008600092236608600092236600860009223660

GMDN Terms#

Term, Definition table
TermDefinition
Image segmentation application softwareAn application software program intended to convert large volumes of slice-based images into manageable three-dimensional (3-D) models of anatomical structures. It is typically used in an electrophysiology (EP) procedure (e.g., a cardiac mapping) to accept DICOM3 images from computed tomography (CT) and magnetic resonance imaging (MRI) scanners. Once the images are imported, a 3-D model can be extracted in a process called segmentation (the isolation of an object of interest) for easy viewing and manipulation during the EP procedure. This device is typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118206040
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009223653Neosoma Glioma22025-03-20
00860009223646Neosoma Dashboard32023-11-14
00860009223622Neosoma Dashboard22023-09-06
00860009223608Neosoma HGG2.1.2.02022-12-22
00860009223615Neosoma Dashboard2.3.2.02022-12-22
00860009223639Neosoma HGG22023-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018318020Bladder AIExo Imaging, Inc.QIH2026-10-22
00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
00850018318082Strain AIExo Imaging, Inc.QIH2026-10-22
03770033463055FETOLYDIAGNOLYQIH2026-10-22
00198953200933Contour ProtégéAIMIM SOFTWARE INC.QKB2026-10-17
05745000308361Cercare Oncology Virtual Expert; CMN Capillary Function with Oncology Virtual ExCercare Medical A/SQIH2026-10-16
19356870000069PHA4DMEDICAL LIMITEDQIH2026-10-13
00198953083246VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083253VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953083260VolusonGE Healthcare Austria GmbH & Co OGQIH2026-10-09
00198953200421EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SQIH2026-10-07
04262352357645DS Core DiagnosisZetta25 AGQIH2026-10-06
00860006442651cmAngioCuremetrix, Inc.QIH2026-10-05
08809887550170EdgeFlow UH10CEdgeCare Inc.QIH2026-09-30
08809887550187EdgeFlow UH10EEdgeCare Inc.QIH2026-09-30
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00850072631097AutoContourRadformation, IncQKB2026-08-25
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23