FDA UDI In Commercial Distribution 🇺🇸 United States

ExamVue

DI: 08809413810174 · Model: ExamVue PACS · JPI HEALTHCARE. CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ExamVue
Primary DI
08809413810174
Version / Model
ExamVue PACS
Company Name
JPI HEALTHCARE. CO., LTD.
Labeler DUNS
687797852
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-04-14
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
27e8f9f6-7122-4d99-8d31-dc8f5b7e6553

Device Description

The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing, modifying, making measurements on, and displaying the images in the database.

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
No
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
40866 Basic diagnostic x-ray system application software

Identifiers

Type ID
Primary 08809413810174