TechCare Trauma

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

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-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
271298427
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
03770018071121RayvolveAZMEDQBS2026-06-04
03770018071138RayvolveAZMEDQBS2026-06-04
03770018071145RayvolveAZMEDQBS2026-06-04
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