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510(k) Data Aggregation
K Number
K970738Device Name
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
Manufacturer
JAMIESON FILM CO.
Date Cleared
1997-05-07
(68 days)
Product Code
IZI
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
JAMIESON FILM CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K971128Device Name
CAP-35B III/CINE 275
Manufacturer
JAMIESON FILM CO.
Date Cleared
1997-04-28
(32 days)
Product Code
IXR
Regulation Number
892.1980Why did this record match?
Applicant Name (Manufacturer) :
JAMIESON FILM CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CAP-35BIII and the CINE 275 are intended to view 35 mm cineangiogram film.
Device Description
The CAP-35BII cineangiogram projector is a continuous film transport 16-facet rotating prism projectors. The CINE 275 is a simpler version of the CAP-35BIII, with fewer options. The CAP-35BIII consists of a 35 mm film projector with built-in viewing hood, a movable cart, a sheet film duplicator, a 35 mm slide camera, a remote control, and an optional TV camera assembly. The CINE 275 consists of a 35 mm film projector with built-in viewing hood and a movable cart.
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K Number
K963334Device Name
JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100
Manufacturer
JAMIESON FILM CO.
Date Cleared
1996-09-11
(16 days)
Product Code
IXX
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
JAMIESON FILM CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.
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K Number
K960043Device Name
KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM
Manufacturer
JAMIESON FILM CO.
Date Cleared
1996-03-27
(84 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
JAMIESON FILM CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
for the indications for use stated in the enclosure
Device Description
Not Found
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