Selenia® Dimensions® C
Selenia Dimensions C-View Software - C-View
Device Description
An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OTE
Device Name: Digital Breast Tomosynthesis
Device Class: 3
Physical State: Hardware and software for acquiring and reconstructing digital projection images. May incorporate similar equipment as full-field digital mammography systems.
Definition: To generate digital 3D mammographic images that can be used for the screening and diagnosis of breast cancer.
Submission Type ID: 2
Review Panel: RA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Projection images are acquired over the stationary breast and reconstructed to produce cross-sectional ¿slices¿ through the breast.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Breast
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device IdentifiersDevice Id: 15420045500020
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A