Compliance Consultants has submitted complex software image
rendering and co-registration applications as PACS viewers. One
recent application was so utterly complete - that the CDRH reviewer
asked no questions- except to strike one word from the "indications for
use" statement and - it was approved.
We submitted many complex software imaging systems to the FDA / CDRH and can submit yours. With DICOM it is possible for a device to search for images using a meaningful query. Key words such as the patient's name. Once received the image can be stored in context with other types that are associated. Explicit semantics also enables software processes to allocate appropriate resources for management of each class of DICOM objects.
DICOM (Digital Imaging and Communications in Medicine) is the industry standard for transfer of radiologic images and other medical information between computers. Patterned after the Open System Interconnection of the International Standards Organization, DICOM enables digital communication between diagnostic and therapeutic equipment and systems from various manufacturers.
This standard specifies a non-proprietary data interchange protocol, digital image format, and file structure for biomedical images and image-related information. The fundamental concepts of the DICOM (message protocol, services, and information objects) are reviewed as background with these attributes
DICOM addresses five general application areas:
(1) Network image management
(2) Network image interpretation management
(3) Network print management
(4) imaging procedure management
(5) Off-line storage media management
DICOM is a complete specification of the elements required to achieve a practical level of automatic interoperability between biomedical imaging computer systems-from application layer to bit-stream encoding. Regulation Number: 21 CFR892.2050, Product Code: LLZ, Radiological Image Processing System.
We submitted many complex software imaging systems to the FDA / CDRH and can submit yours. With DICOM it is possible for a device to search for images using a meaningful query. Key words such as the patient's name. Once received the image can be stored in context with other types that are associated. Explicit semantics also enables software processes to allocate appropriate resources for management of each class of DICOM objects.
DICOM (Digital Imaging and Communications in Medicine) is the industry standard for transfer of radiologic images and other medical information between computers. Patterned after the Open System Interconnection of the International Standards Organization, DICOM enables digital communication between diagnostic and therapeutic equipment and systems from various manufacturers.
This standard specifies a non-proprietary data interchange protocol, digital image format, and file structure for biomedical images and image-related information. The fundamental concepts of the DICOM (message protocol, services, and information objects) are reviewed as background with these attributes
- The functionality of DICOM
- The innovations and limitations of the Standard
- The impact of various DICOM features on information system users
DICOM addresses five general application areas:
(1) Network image management
(2) Network image interpretation management
(3) Network print management
(4) imaging procedure management
(5) Off-line storage media management
DICOM is a complete specification of the elements required to achieve a practical level of automatic interoperability between biomedical imaging computer systems-from application layer to bit-stream encoding. Regulation Number: 21 CFR892.2050, Product Code: LLZ, Radiological Image Processing System.
Many of Compliance Consultants' recent projects have been DICOM compliant PACS image systems that present Radiological Images on a multitude of various review platforms.
