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Xmaru Pro

FDA UDI

Class II (US FDA UDI)

by Rayence Co., Ltd.

Identity

Trade Name
Xmaru Pro FDA UDI
Generic Name
Basic diagnostic x-ray system application software FDA UDI
Device Name
Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals. FDA UDI
Model / Reference
Xmaru Pro FDA UDI
Description
Xmaru Pro software carries out the image processing and administration of medical X-ray data which includes adjustment of window leveling, rotation, zoom, measurements, automated measurement of bone age from a child's hand X-ray, and function to assist the image reading by detecting abnormal areas on the chest X-ray. Xmaru Pro is complying with DICOM standards to assure optimum communications between network systems. (not approved for mammography) Xmaru Pro offered as a stand-alone imaging solution to be installed in a PC for trained medical professionals. FDA UDI

Identifiers

Primary DI / UDI-DI
08800018600580 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 Pro 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 51948cd4-e0f2-48f3-859f-f5b3c5d5a959 35 fields · synced May 31, 2026