FDA.reportPublic FDA data

XmaruView V1

Primary DI
08800018600610
Brand
XmaruView V1
Company
Rayence Co., Ltd.
Model
XmaruView V1
Device description
XmaruView V1 is a software program designed to provide image acquisition, processing and operational management functions for digital radiography. XmaruView V1 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. XmaruView V1 provides a streamlined process of multiple workflows. This optimizes any hospital environment for digital radiography.
Published
2020-07-24
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
K190866000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190866000XmaruView V1 (Xmaru Chiroview, Xmaru Podview)Rayence Co., Ltd.2019-04-30LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800018600610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800018600610088000186006108800018600610

GMDN Terms#

Term, Definition table
TermDefinition
Basic x-ray clinical assessment support softwareA software program intended to display, analyse/process, and possibly acquire static two-dimensional (2-D) x-ray images of bones and/or the abdominothoracic region, acquired by a basic diagnostic x-ray system, to support a healthcare provider with clinical assessment (e.g., diagnosis, triage, image quality assessment) of a trauma or condition (typically orthopaedic, cardiac or pulmonary). It is not dedicated to treatment planning and does not incorporate adaptive/dynamic machine learning (ML) models.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

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
08800018600399XmaruView V1XmaruView V12016-09-16
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745426000059MiPACS V5Medicor ImagingLLZ2026-10-12
75401622522132Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-10-08
00198953200421EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
00198953200438EchoPACGE Vingmed Ultrasound A/SLLZ2026-10-07
17540262200126Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-10-05
00884838120433SmartCTPhilips Medical Systems Nederland B.V.LLZ2026-09-28
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
B141MEDISSUITEMRCT20260Medis Suite MRCTMedis Medical Imaging Systems B.V.LLZ2026-09-25
00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
05745000308323Cercare Medical Neurosuite with Capillary FunctionCercare Medical A/SLLZ2026-01-30
05745000308330Cercare Medical Neurosuite (CMN) Capillary Function with Virtual ExpertCercare Medical A/SLLZ2026-01-30
00198953076873SenoIrisGE MEDICAL SYSTEMSLLZ2025-11-24
00195278951700EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
00195278951717EchoPACGE Vingmed Ultrasound A/SLLZ2025-08-08
03663999000375spineEOSEOS IMAGINGLLZ2025-08-01
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00884838127746Radiology Operations Command Center ConsolePhilips Medical Systems Nederland B.V.LLZ2025-03-14
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
07613252196259FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29