Identity
- Trade Name
- Xmaru Podview FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. FDA UDI
- Model / Reference
- Xmaru Podview FDA UDI
- Description
- Xmaru Podview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Podview performs connects with flat-panel detectors and generator to acquire digital images. The software also manages information on patients, tests and images through an internal database. It also supports DICOM which allows excellent compatibility with other radiography equipment and network programs. Xmaru Podview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018600597 FDA UDI
- 510(k) Number
- K190866 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Basic diagnostic x-ray system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
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
Yes
FDA UDI
Category: Basic diagnostic x-ray system application software
Xmaru Podview by Rayence Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190866 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
- Rayence Co., Ltd.
Sources (1)
- FDA UDI 30f3c12a-1968-4188-8e1f-458c1c4cac99 35 fields · synced May 31, 2026