INFINITT Healthcare Co.,Ltd.

Address:12F Daerung Post Tower III,SEOUL,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (10)

Premarket Exempt

No Yes

Clear

STARPACS - 08809278790000 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

INFINITT PACS - 08809278790055 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

INFINITT Cardiology PACS - 08809278790062 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xelis - 08809278790079 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xelis 3D - 08809278790086 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xelis Fusion - 08809278790093 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xelis Cardiac - 08809278790109 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Xelis Dental - 08809278790116 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

INFINITT ULite - 08809278790123 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

INFINITT PACS - 08809278790130 Catalog Number :

Device Class : 2

Duns Number: 688319156

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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