FDA.report

PACSCore

Primary DI
B295PACSCORE60
Brand
PACSCore
Company
Radius
Model
6
Device description
PACSCore back-end archive
Published
2016-09-19
Public version status
Update
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

Product Codes

CodeName
LLZSystem, Image Processing, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications

CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B295PACSCORE60PrimaryHIBCC0

GMDN Terms

TermDefinition
Radiology picture archiving and communication system digital archive deviceA mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080220305
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
B295VNA70Vendor Neutral Archive with ConnectWeb72019-07-31
B295FULLPACS30ConnectWeb with PACSCore32016-09-19
B295VBA10ViewBox Advanced12016-09-19
B295VBB60ViewBox Basic62016-09-19

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