← Back to catalogue
Radiological Image Processing System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref ExamVue Duo
Identity
- Trade Name
- ExamVue FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- Radiological Image Processing System EUDAMEDExamVue 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. FDA UDI
- Model / Reference
- ExamVue Duo EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809413810679 EUDAMEDFDA UDI
- Basic UDI-DI
- 880941381ExamVueXM EUDAMED
- 510(k) Number
- K213057 FDA UDI
- FDA Product Code
- KPR FDA UDI
- EMDN Code
- Z11030582 RADIOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Radiological Image Processing System by Jpi Healthcare. Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213057 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 880941381ExamVueXM | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- JPI Healthcare Co., Ltd.
- EUDAMED SRN
- KR-MF-000002016
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED e775d936-5942-490d-acdd-a4ee6559b20e 61 fields · synced Jun 19, 2026
- FDA UDI 833527f0-6067-4eda-a28d-c573b77886b7 34 fields · synced May 30, 2026
- FDA 510(k) K213057 1 fields · synced May 18, 2026