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510(k) Data Aggregation
K Number
K981834Device Name
PERCEPTION INC, GPS-6TBMD DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1998-09-29
(126 days)
Product Code
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
PERCEPTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Small Organ (Breast, Thyroid, Testes), Cardiac, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional.
Device Description
The Perception's GPS-6TBMD Ultrasound System is a PC (computer) based and controlled real time. two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-6TBMD Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-6TBMD Diagnostic Ultrasound System supports M. B. M&B, Dual B, Quad B, D and D/B, display modes. All probes currently intended for use with the Perception GPS-6TBMD Diagnostic Ultrasound System are either mechanical sector devices or electronic linear and curve array, and make use of a fluid filled design.
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K Number
K974880Device Name
PERCEPTION GPS-RST DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1998-06-08
(160 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
PERCEPTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Peripheral Vascular.
Device Description
The Perception's GPS-RST Ultrasound System is a PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-RST Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-RST Diagnostic Ultrasound System supports M, B, M&B, Dual B, Quad B. D and D/B, display modes. All probes currently intended for use with the Perception GPS-RST Diagnostic Ultrasound System are either mechanical sector devices or electronic linear array, and make use of a fluid filled design.
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K Number
K972192Device Name
PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1997-12-17
(190 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
PERCEPTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GPS-XYZ device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device.
Device Description
The GPS-XYZ Diagnostic Ultrasound System device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There are no transcranial applications for this device.
User interface is via an alphanumeric keypad and integrated trackball. The Perception Inc. GPS-XYZ Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS -XYZ Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes.
All probes currently intended for use with the Perception Inc. GPS -XYZ Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.
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K Number
K972973Device Name
PERCEPTION INC. GPS-TUV DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer
Date Cleared
1997-10-15
(65 days)
Product Code
Regulation Number
892.1560Why did this record match?
Applicant Name (Manufacturer) :
PERCEPTION, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The GPS-TUV device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There is no transcranial application for this device.
Device Description
The GPS-TUV Diagnostic Ultrasound System device is a PC (Computer) based and controlled real time, two-dimensional, mechancial sector and electronic array diagnostic ultrasound system which produces diagnostic ultrasonic images through a user friendly operation. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 3.0-12.5 MHZ. There are no transcranial applications for this device. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-TUV Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS-TUV Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -TUV Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design.
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