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510(k) Data Aggregation
K Number
K112539Device Name
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
Manufacturer
Date Cleared
2012-01-30
(151 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
**LEIKER REGULATORY **& QUALITY CONSULTING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The system is a general-ourpose ultrasonic imstrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal.Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application: Fetal Imaging & Other, Cardiac, Peripheral Vessel
Specific: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, parathyroid, parotid,submaxillary gland, testes and breast.), Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Urology, Ob/GYN, Cardiac Pediatric, Peripheral vessel
Device Description
The SONO TOUCH Series ultrasound system is an integrated preprogrammed ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications.
The CHISON ultrasound system is configured as a portable model (SONO TOUCH Series). These systems are designed with the latest technology, using the same quality procedure as ultrasound systems, which have been available in the market for years.
This CHISON ultrasound system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound echo data and display the image in B-Mode (including Tissue Harmonic Imaging), M-Mode, or a combination of these modes.
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