AccessGUDID - DEVICE: Xmaru Pro (08800018600580)

GUDID

Device Identifier (DI) Information

Brand Name: Xmaru Pro
Version or Model: Xmaru Pro
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rayence Co., Ltd.

Primary DI Number: 08800018600580
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 557804458 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40866	Basic diagnostic x-ray system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190866	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51948cd4-e0f2-48f3-859f-f5b3c5d5a959
Public Version Date: August 03, 2020
Public Version Number: 1
DI Record Publish Date: July 24, 2020