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510(k) Data Aggregation
K Number
K991282Device Name
COLORPOINT 1720 MEDICAL IMAGERS AND VIDEO CAPTURE BOX CX-1000 SERIES
Manufacturer
SEIKO INSTRUMENTS USA, INC.
Date Cleared
1999-06-30
(77 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
SEIKO INSTRUMENTS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Seiko ColorPoint™ model 1700 medical imager & Video Capture Box systems are indicated for converting the electronic signals from medical imaging modalities into hard copy suitable for diagnosis and record keeping.
Device Description
The Seiko ColorPoint™ Medical Imager and Video Capture systems are designed for medical imaging applications printing color or monochrome images on paper and or film media.
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K Number
K971760Device Name
COLORPOINT OR PROFESSIONAL COLORPOINT
Manufacturer
SEIKO INSTRUMENTS USA, INC.
Date Cleared
1997-10-01
(142 days)
Product Code
LMC
Regulation Number
892.2040Why did this record match?
Applicant Name (Manufacturer) :
SEIKO INSTRUMENTS USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for producing full-bleed thermal wax prints in various sizes from medical image signal inputs.
Device Description
Color point 820 PS, 830 Ps and Professional Colorpoint 2 Model 04.
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