FDA.report

Ambra Health Mobile Application

Primary DI
AMBRMOBILEAPP0
Brand
Ambra Health Mobile Application
Company
Ambra Health
Model
AMBRMOBILEAPP0
Device description
Mobile Application version of Ambra Health. Not intended for diagnostic purposes.
Published
2019-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
AMBRMOBILEAPP0PrimaryHIBCC0

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
888-315-0790compliance@ambrahealth.com

Regulatory Flags

DUNS number
012054504
Device count
1
DM exempt
false
Premarket exempt
true
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
AMBRAPACS0Ambra PACS3.242024-01-24
AMBRHEALTHSOLUTIONS0Ambra PACS3.16.10.02016-10-10

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