FDA.report

Ambra PACS

Primary DI
AMBRAPACS0
Brand
Ambra PACS
Company
Ambra Health
Model
3.24
Published
2024-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
AMBRAPACS0PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiology information systemA dedicated computerized radiology information system (RIS) designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and generation of work lists for specific radiological systems, and in conjunction with a picture archiving and communication system (PACS). The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).

Sterilization Methods

Method

Contacts

PhoneEmail
888-315-0790support@ambrahealth.com

Regulatory Flags

DUNS number
012054504
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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 DIBrandModelCatalogPublished
AMBRMOBILEAPP0Ambra Health Mobile ApplicationAMBRMOBILEAPP02019-04-01
AMBRHEALTHSOLUTIONS0Ambra PACS3.16.10.02016-10-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08809985659300R2GATE WindowsMegagen Implant Co. LtdLLZ2026-03-24
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.LLZ2026-03-24
05404028000861Mimics Thoracic PlannerMaterialise NVLLZ2026-03-20
17540262140255Change Healthcare Stratus Imaging ViewerChange Healthcare Canada CompanyLLZ2026-03-19
08800018412008EConsole2DRTECH CorporationLLZ2026-03-17
75401622502288Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-03-17
00860010575314AS SoftwareAs Software, LLCLLZ2026-03-10
00860010575321AS SoftwareAs Software, LLCLLZ2026-03-10
04719878870009EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870108EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870122EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870191EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870276EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
04719878870290EBMEBM TECHNOLOGIES INCORPORATEDLLZ2026-03-10
09358140000079Quicktome Software SuiteOmniscient Neurotechnology Pty Ltd (o8t)LLZ2026-03-09
17540262090154Change Healthcare CardiologyChange Healthcare Canada CompanyLLZ2026-03-09
06971576834334uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
06971576834341uWSShanghai United Imaging Healthcare Co., Ltd.LLZ2026-03-08
07350092810678Sectra Orthopedic PackageSectra ABLLZ2026-03-05
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LLZ2026-02-27
08800169200134ON3D3D ONS, INC.LLZ2026-02-19
B403IQS11004iQ-SYSTEM PACSIMAGE Information Systems Europe GmbHLLZ2026-02-19
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
00860015443526CARPLCarpl.AI, Inc.LLZ2026-02-16
00862234000320vRad ViewervRadLLZ2026-02-13
04260489720202mediCAD® WebmediCAD Hectec GmbHLLZ2026-02-11
75401622502271Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-02-10
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDLLZ2026-02-03
B720BX360ECTP1420e-CTPBRAINOMIX LIMITEDLLZ2026-02-03