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510(k) Data Aggregation
K Number
K063188Device Name
DEL-IMS
Manufacturer
Date Cleared
2006-11-30
(41 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
DEL MEDICAL IMAGING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DEL-IMS has application wherever the transmission of radiographic images and associated patient text data is desired to take place from an input, such as radiographic equipment which employs a digital image capture device, to an output device such as hardcopy, softcopy, or archive device.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Device Description
The DEL-IMS is intended to provide a network connection via DICOM protocol to various output (e.g. hardcopy, softcopy and archive) devices from a radiographic system which uses a digital image capture device. It synchronizes the ready states of the digital image capture device and the radiographic equipment when a single x-ray console is desired, to provide the x-ray console features (e.g. technique selection) of the radiographic equipment.
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K Number
K992037Device Name
MAMEX
Manufacturer
Date Cleared
1999-07-30
(44 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
DEL MEDICAL IMAGING CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The option intended to provide the operator with the capabilities of selecting Rhodium filtration for enhanced image quality.
Device Description
Rhodium filtration option for use with "Mamex" Mammographic X- Ray system.
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