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510(k) Data Aggregation
K Number
K250750Device Name
INNOVISION-P5
Manufacturer
DK Medical Systems Co., Ltd
Date Cleared
2025-07-18
(128 days)
Product Code
IZL
Regulation Number
892.1720Why did this record match?
Applicant Name (Manufacturer) :
DK Medical Systems Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K242119Device Name
INNOVISION-EXII
Manufacturer
DK Medical System
Date Cleared
2025-01-03
(168 days)
Product Code
KPR
Regulation Number
892.1680Why did this record match?
Applicant Name (Manufacturer) :
DK Medical System
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INNOVISION-EXII is a stationery X-ray system intended for obtaining radiographic images of various anatomical parts of the human body, both pediatrics and adults, in a clinical environment. INNOVISION-EXII is not intended for mammography, angiography, interventional, or fluoroscopy use.
Device Description
INNOVISION-EXII can receive X-ray signals from X-ray irradiation and digitize them into X-ray images by converting digital images to DICOM image format using Elui imaging software. INNOVISION-EXII is a general radiography X-ray system and not for mammography nor fluoroscopy. In addition, the system must be operated by a user who is trained and licensed to handle a general radiography X-ray system to meet the regulatory requirements of a Radiologic Technologist. Target areas for examinations include the head, spine, chest, and abdomen for diagnostic screening of orthopedic, respiratory, or vertebral discs. The system can capture a patient's postures, such as sitting, standing, or lying. This system can be used for patients of all ages, but it should be used with care for pregnant women and infants. The INNOVISION-EXII system has no part directly touching the patient's body.
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