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510(k) Data Aggregation
K Number
K092204Device Name
PMD VIEWER
Manufacturer
SPENCER TECHNOLOGIES
Date Cleared
2009-10-08
(78 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SPENCER TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMD Viewer Software is intended to provide off-line data viewing, playback, and report generation features of transcranial TCD100M/PMD150 Doppler ultrasound studies on a PC. PMD Viewer may only be operated independently, as a software-only product. PMD Viewer is intended for use by a technologist or physician trained in the use of Doppler ultrasound. PMD Viewer is NOT intended to replace any means of evaluating vital patient physiological processes. No new intended uses are claimed.
Device Description
This device is a software-only version of the Spencer Technologies digital Transcranial Doppler ultrasound system, the TCD100M/PMD150, and is described as the PMD Viewer.
The modification of the TCD100M/PMD150 implemented in the PMD Viewer provides physicians and technologists with the same data viewing, playback, and report generation features of the TCD100M/PMD150 off-line on a standard PC utilizing Windows XP SP2 or VISTA. All software features can be controlled with a standard keyboard and wheel mouse. Because it can read the proprietary binary file formats of the predicate (parent) device, the TCD100M/PMD150, the PMD Viewer displays images without any compression, duplicating the original quality of the images on the TCD100M/PMD150.
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K Number
K002533Device Name
TCD 100M, PWD13 TRANSDUCER
Manufacturer
SPENCER TECHNOLOGIES
Date Cleared
2000-08-30
(14 days)
Product Code
IYN
Regulation Number
892.1550Why did this record match?
Applicant Name (Manufacturer) :
SPENCER TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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