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Xmaru Chiroview

FDA UDI

Class II (US FDA UDI)

by Rayence Co., Ltd.

Identity

Trade Name
Xmaru Chiroview FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Device Name
Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview 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 Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. FDA UDI
Model / Reference
Xmaru Chiroview FDA UDI
Description
Xmaru Chiroview is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. Xmaru Chiroview 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 Chiroview provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography. FDA UDI

Identifiers

Primary DI / UDI-DI
08800018600603 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 Chiroview 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.

Cleared under the same submission

K190866 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rayence Co., Ltd.

Sources (1)

  • FDA UDI bc4d11b3-6a01-4cc3-b129-8c5d8281c0d6 35 fields · synced May 30, 2026