| Primary Device ID | 08809413810488 | 
| NIH Device Record Key | 6ca8e00f-cca7-41f6-8e71-17226e02a924 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Box for ExamVue DR(outside 265mmx185mmx150mm) | 
| Version Model Number | ExamVue DR | 
| 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 | true | 
| Serial Number | true | 
| Manufacturing Date | true | 
| 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 | 
| 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) | 2020-04-20The ExamVue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3rd party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue DR software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol. | 
| 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 |