FDA.reportPublic FDA data

Xelis Cardiac

Primary DI
08809278790109
Brand
Xelis Cardiac
Company
INFINITT Healthcare Co.,Ltd.
Model
Xelis Cardiac
Published
2017-09-19
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
K111660000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111660000XELIS CARDIACInfinitt Co., Ltd.2011-09-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809278790109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809278790109088092787901098809278790109

Regulatory Flags#

DUNS number
688319156
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
08809278790000STARPACSSTARPACS2017-06-05
08809278790062INFINITT Cardiology PACSINFINITT Cardiology PACS2017-09-19
08809278790079XelisXelis2017-09-19
08809278790086Xelis 3DXelis 3D2017-09-19
08809278790093Xelis FusionXelis Fusion2017-09-19
08809278790116Xelis DentalXelis Dental2017-07-06
08809278790123INFINITT ULiteINFINITT ULite2017-07-06
08809278790130INFINITT PACSINFINITT PACS 7.02017-12-06
08809278790017STARPACS Orthopedics SystemSTARPACS Orthopedics System2023-06-09
08809278790024RapidiaColon SystemRapidiaColon System2023-06-09
08809278790031STARPACS DentalSTARPACS Dental2023-06-09
08809278790048Reformat GatewayReformat Gateway2023-06-09
08809278790055INFINITT PACS, INFINITT G3, INFINITT MammoINFINITT PACS2017-06-05
08809278790345INFINITT RT MobileINFINITT RT Mobile2022-08-25
08809278790192INFINITT RT PACSINFINITT RT PACS2021-11-18
08809278790307Xelis Dental 2.0Xelis Dental 2.02021-11-18
08809278790291INFINITT DPSINFINITT DPS2026-01-29

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Primary DI, Brand, Company table
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B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
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05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20