Identity
- Trade Name
- ExamVue FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- The 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. FDA UDI
- Model / Reference
- ExamVue DR FDA UDI
- Description
- The 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809413810143 FDA UDI
- 510(k) Number
- K142930 FDA UDI
- FDA Product Code
- KPR FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic diagnostic x-ray system application software
ExamVue by Jpi Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142930 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jpi Healthcare, Inc.
Sources (1)
- FDA UDI 02a2d75b-2b44-4cd3-b959-f7f875f414e9 34 fields · synced May 30, 2026