TechCare Trauma

Primary DI
03770024774047
Brand
TechCare Trauma
Company
MILVUE
Model
V1.1.x
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBSRadiological Computer Assisted Detection/Diagnosis Software For FractureRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242171000TechCare TraumaMilvue2025-01-17QBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770024774047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770024774047037700247740473770024774047

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS softwareAn individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
271298427
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770024774016SmartChestV2.x.x2025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B621ICOBRAINARIA1X2Y0icobrain ariaicometrix NVQBS2025-10-24
B621ICOBRAINARIA1X1Y0icobrain ariaicometrix NVQBS2025-02-18
03770018071060RayvolveAZMEDQBS2024-10-11
03770018071077RayvolveAZMEDQBS2024-10-11
03770018071084RayvolveAZMEDQBS2024-10-11
03770018071008RayvolveAZMEDQBS2024-06-10
03770018071015Rayvolve AZMEDQBS2024-03-18
03770018071022RayvolveAZMEDQBS2024-03-18
00195278789365Critical Care SuiteGE Medical Systems, L.L.C.QBS2023-10-19
03770020839085BoneViewGLEAMERQBS2023-03-16
03770020839009BoneViewGLEAMERQBS2022-04-20
00852491008016FractureDetect (FX)Imagen Technologies, Inc.QBS2021-04-12