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510(k) Data Aggregation
K Number
K220983Device Name
ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System
Manufacturer
Date Cleared
2022-11-11
(221 days)
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
ImSonic Medical China, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ImSonic TR-1 Ultrasonic pulsed doppler imaging system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. The system is intended to be used in a hospital or clinic setting. Specific clinical applications and exam types include:
Fetal/obstetric
Gynecological /Pelvic
Abdominal
Renal
Cardiac
Pediatric
Small organ (thyroid, breast, testes, etc.)
Musculoskeletal (conventional & superficial)
Peripheral vascular
Ophthalmic
Modes of operation include B, M, PWD(PW), Color Doppler (C), B+M, B+Color Doppler, B+PWD, Biopsy, Harmonics (Tissue), Contrast Imaging (CPS), Steered Spatial Compounding (SSC).
Device Description
The ImSonic TR-1 is a general purpose, mobile Ultrasonic Pulsed Doppler Imaging System. The function is to acquire ultrasound data and to display in various modes of operation. The device consists of two parts: the system console and the transducers. The system console contains the user interface, a display, a touch screen, a control panel, system electronics and optional peripherals (barcode scanner, printer). The removable transducers are connected to the system using a standard technology, multipin connectors.
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