FDA.reportPublic FDA data

XmaruView V1

Primary DI
08800018600399
Brand
XmaruView V1
Company
Rayence Co., Ltd.
Model
XmaruView V1
Device 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
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160579000Xmaru View V1 and Xmaru PACS, Medical Image Processing SoftwareRayence Co., Ltd.2016-04-08LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018600399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018600399088000186003998800018600399

Regulatory Flags#

DUNS number
557804458
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800018600429Xmaru PACSXmaru PACS2016-10-11
08800018600573ClearON MobileClearON Mobile2019-03-08
08800018600580Xmaru ProXmaru Pro2020-07-24
08800018600597Xmaru PodviewXmaru Podview2020-07-24
08800018600603Xmaru ChiroviewXmaru Chiroview2020-07-24
08800018600610XmaruView V1XmaruView V12020-07-24
088000186022562430TCA2430TCA2025-04-08
088000186022181717WCE1717WCE2024-09-19
088000186022251717WCE-HR1717WCE-HR2024-09-19
088000186022321717WCE-HS1717WCE-HS2024-09-19
088000186022491717WCE-GF1717WCE-GF2024-09-19
088000186021950909FCC0909FCC2024-03-21
088000186022010909FCC-HS0909FCC-HS2024-03-21
088000186021401417WCE1417WCE2023-06-29
088000186021571417WCE-HR1417WCE-HR2023-06-29
088000186021641417WCE-HS1417WCE-HS2023-06-29
088000186021711417WCE-GF1417WCE-GF2023-06-29
08800018600924Vatech Clismile11-12112022-05-31
08800018600931Vatech Clismile 11-12212022-05-31
08800018600948Vatech Clismile 11-12122022-05-31

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