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510(k) Data Aggregation
K Number
K243296Device Name
Disposable Biopsy Needle
Manufacturer
Carbon (Shenzhen) Medical Device Co., Ltd.
Date Cleared
2025-07-11
(266 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
Carbon (Shenzhen) Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K243298Device Name
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System
Manufacturer
Carbon (Shenzhen) Medical Device Co., Ltd.
Date Cleared
2025-04-03
(167 days)
Product Code
IYN, ITX, IYO
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
Carbon (Shenzhen) Medical Device Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is applicable for adults. It is intended for use in abdominal, superficial organs, trans-rectal, musculo-skeletal, peripheral vessel, urology exams.
Modes of operation include: B, B+C, B+C+D(PW), B+M Mode, Image fusion, Needle Line.
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Device Description
Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System is a medical, real-time, high-resolution ultrasound diagnosis system. It has a 24" multi-directional swiveled (non-touch) LCD monitor, a secondary 17" touch-display and cart. The System offers B, C, D, M Mode, as well as FUSION Mode which could synthesis real-time US images and preoperative images, such as CT and MRI. It could be equipped with convex-array, linear-array and intracavitary tracked probes, that supporting a wide range of clinical applications.
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