Identity
- Trade Name
- XmaruView V1 FDA UDI
- Generic Name
- Basic diagnostic x-ray system application software FDA UDI
- Device Name
- XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management FDA UDI
- Model / Reference
- XmaruView V1 FDA UDI
- Description
- XmaruView V1 is a radiographic image acquisition and image data management program in charge of variety of image related functions, including photographing Digital Radiography, acquiring and processing the images, and the image management FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800018600399 FDA UDI
- 510(k) Number
- K160579 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
XmaruView V1 by Rayence Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic diagnostic x-ray system application software.
- ProFound AI V3.0 — Icad, Inc. · Class II
- i-Dixel — J.MORITA MFG.CORP. · Class II
- PowerLook AMP SLD GE US — Icad, Inc. · Class II
- PowerLook AMP PRO with SecondLook Digital — Icad, Inc. · Class II
- PowerLook AMP SLD Giotto — Icad, Inc. · Class II
- sterEOS® — Eos Imaging, Inc. · Class II
- Visix — Televere Systems · Class II
- TigerView — Televere Systems · Class II
Cleared under the same submission
K160579 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rayence Co., Ltd.
Sources (1)
- FDA UDI 80a6b85f-8eb8-4299-863b-48145dc0945b 34 fields · synced May 31, 2026