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510(k) Data Aggregation
K Number
K973125Device Name
MAMMOLOADER BY C.M.A. SRL
Manufacturer
Date Cleared
1997-10-08
(49 days)
Product Code
Regulation Number
892.1900Why did this record match?
Applicant Name (Manufacturer) :
C.M.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MAMMOLOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.
Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.
Device Description
The MAMMOLOADER will be used to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.
Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.
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