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510(k) Data Aggregation
K Number
K150002Device Name
iNSIGHT Color Doppler Ultrasound System
Manufacturer
Date Cleared
2015-06-23
(172 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SASET (CHENGDU) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iNSIGHT Color DopplerUltrasound System is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets.
Device Description
The iNSIGHT Color Doppler Ultrasound Systems are integrated preprogrammed color ultrasound imaging system, capable of producing a resolution intended for clinical diagnostic imaging applications. Their basic function is to acquire ultrasound signal and display the images in the following imaging operations: B, M, PW, CW, CDI, PDI, DPDI, TDI, MC and THI imaging mode, Spatial Compounding Imaging, Panoramic B and Color mode, Freehand 3D, 4D Imaging, Strain imaging, ARFI Elasticity Imaging.
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K Number
K090059Device Name
IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
2009-04-30
(111 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
SASET (CHENGDU) INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The iMago c21 medical ultrasound system is intended for visualization of ultrasound of internal organs, for medical diagnostic purposes only. The main applications are: General radiology, Abdominal (excluding fetal Doppler), Vascular, OB/GYN, Urology, Breast, Superficial Organ (Small Parts), Musculoskeletal, and Cardiology. Each application includes a set of exams, including the specific measurements, reports, pictograms, annotations and system presets. The detailed application is listed in the User Guide-and-all these applications must be operated by qualified and trained Physician or "Sonographer".
Device Description
The iMago c21 Diagnostic Ultrasound System is highly mobile, software-controlled, totally digital processing and PC-based ultrasound imaging system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow(including amplitude Doppler). The system can generate real-time compound images and harmonic images, as well as 3D images and Wide-Field-of-View images. The system is designed for use in convex and linear scanning modes, and supports convex and linear array probes.
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