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510(k) Data Aggregation
K Number
K961229Device Name
HR12000 ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1997-05-29
(426 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
INTERNATIONAL ULTRASOUND CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HRT2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers optional probes each type optimized to image structure and orienation of tissues during specific opinical applications. These include general abdominal, small organ, gyneeological and urological, vascular and cardiac anatomy.
Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Device Description
HRI 2000 Ultrasound System
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