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510(k) Data Aggregation
K Number
K992378Device Name
DIAGNOSTIC ULTRASOUND, MODEL 1.0
Manufacturer
Date Cleared
1999-09-29
(75 days)
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
VOLUMETRICS MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic Ultrasound
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Cardiac, Peripheral Vascular.
Mode of Operation: A, B, M, PWD, Color Doppler, Amplitude Doppler, Combined (Single B mode or multi-B mode will operate in single combination with M-Mode, or PWD, or color Doppler, or amplitude Doppler), Other (Contrast Harmonics mode to optimize the image when using contrast media).
Device Description
Model 1.0 Diagnostic Ultrasound System with Contrast Harmonic Imaging. Addition of Contrast Harmonics mode to optimize the image when using contrast media. Contrast Harmonic modes will utilize second harmonics.
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K Number
K982498Device Name
DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1998-08-07
(21 days)
Product Code
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
VOLUMETRICS MEDICAL IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic Ultrasound
Fetal, Abdominal, Pediatric, Small Organ (Testes, adult female breast, and thyroid), Neonatal Cephalic, Cardiac, Peripheral Vascular
Device Description
Model 1.0 Diagnostic Ultrasound System
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