FDA UDI In Commercial Distribution 🇺🇸 United States

PACSCore

DI: B295PACSCORE60 · Model: 6 · Radius
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
PACSCore
Primary DI
B295PACSCORE60
Version / Model
6
Company Name
Radius
Labeler DUNS
080220305
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-19
Public Version
4
Public Version Date
2019-06-27
Public Version Status
Update
Public Device Record Key
5c66d36c-8955-4352-ae83-1b3eb432c8d7

Device Description

PACSCore back-end archive

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LMD System, Digital Image Communications, Radiological

GMDN Terms

Code Name
41669 Radiology picture archiving and communication system digital archive device

Identifiers

Type ID
Primary B295PACSCORE60