FDA.reportPublic FDA data

BoneView

Primary DI
03770020839009
Brand
BoneView
Company
GLEAMER
Model
1.X-US
Published
2022-04-20
Public version status
Update
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
K212365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212365000BoneViewGleamer2022-03-01QBS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03770020839009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03770020839009037700208390093770020839009

GMDN Terms#

Term, Definition table
TermDefinition
Radiology 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. It is designed specifically for use within radiology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
281142375
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03770020839092ChestView US1.0.X2025-04-02
03770020839108BoneMetrics US1.0.X2025-04-02
03770020839085BoneView1.1.X2023-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B621ICOBRAINARIA1X2Y0icobrain ariaicometrix NVQBS2025-10-24
03770024774047TechCare TraumaMILVUEQBS2025-03-31
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
00852491008016FractureDetect (FX)Imagen Technologies, Inc.QBS2021-04-12