ExamVue

GUDID 08809413810679

ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.

JPI HEALTHCARE. CO., LTD.

Basic diagnostic x-ray system application software

• Primary Device ID: 08809413810679
• NIH Device Record Key: 833527f0-6067-4eda-a28d-c573b77886b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExamVue
• Version Model Number: ExamVue Duo
• Company DUNS: 687797852
• Company Name: JPI HEALTHCARE. CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809413810679 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213057

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by JPI HEALTHCARE. CO., LTD.

• 08809413810679 - ExamVue: 2023-06-23ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for digital radiography and use by radiologists and radiology technicians. ExamVue Duo saves the digital X-ray images acquired from the detector and process it to make the better image quality. The software also manages patient information, capture, and store diagnostic images in an internal database. It also supports DICOM 3.0 protocol which allows compatibility with the network programs such as the PACS system.
• 08809413810679 - ExamVue: 2023-06-23 ExamVue Duo is a software program designed to provide image acquisition, processing and operational management functions for dig
• 08809413810471 - Box for ExamVue PACS(outside 265mmx185mmx150mm): 2020-04-20 The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consis
• 08809413810488 - Box for ExamVue DR(outside 265mmx185mmx150mm): 2020-04-20 The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray image
• 08809413810464 - Radiographic Grid: 2020-04-14 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typi
• 08809413810204 - Radiographic grid: 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists
• 08809413810211 - Radiographic Grid: 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging or mammography. It typi
• 08809413810266 - Box for radiographic Grid-1000(9"x11"(outside 345mmx329mm)): 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists
• 08809413810273 - Box for radiographic Grid-1000(11"x13"(outside 395mmx380mm)): 2020-03-04 A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists