FDA.reportPublic FDA data

Ambra PACS

Primary DI
AMBRHEALTHSOLUTIONS0
Brand
Ambra PACS
Company
Ambra Health
Model
3.16.10.0
Published
2016-10-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152977000DG PACSDicom Grid, Inc.2016-01-25LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
AMBRHEALTHSOLUTIONS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
AMBRAPACS0Ambra PACS3.242024-01-24
AMBRMOBILEAPP0Ambra Health Mobile ApplicationAMBRMOBILEAPP02019-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850631008858Roentgen WorksBrit Systems, LLCLLZ2026-05-26
08800130400228Neurophet SCALE PETNEUROPHET Inc.LLZ2026-05-26
08800130400310Neurophet AQUANEUROPHET Inc.LLZ2026-05-26
00888118154231IPSKLS-Martin L.P.LLZ2026-05-25
05404028007006OrthoViewMaterialise NVLLZ2026-05-22
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