3.1. Pre-delivery 3.1.2 Parameter Actor Requirement The trial camera (and any replacements parts) must pass all Manufacturer manufacturing in-process and release testing criteria Release Testing Non-OEM parts All parts and accessories must meet or exceed OEM specifications supplier and pass all release testing criteria Shall meet the Conformance Statement written by manufacturer DICOM format Manufacturer of each system All workstations used to process images must be validated, able Computer to support the image file type generated by the gamma camera Vendor workstations and able to perform the image reconstruction and analysis requirements detailed in Sections 3.7 and 3.10. Owned by A camera system should be used that meets the requirements imaging center; detailed under Image Data Acquisition in Section 3.6. This includes Camera System placed by specific requirements for the collimator, projection bin (pixel) technologist size, head-holder, etc. 3.2 INSTALLATION AND 3.2.2
3.1. Pre-delivery 3.1.2 Parameter Actor Requirement Release Testing Manufacturer The camera (and any replacements parts) must pass all manufacturing in-process and release testing criteria Non-OEM parts supplier All parts and accessories must meet or exceed OEM specifications and pass all release testing criteria DICOM format Manufacturer Shall meet the Conformance Statement written by manufacturer of each system Computer workstations Vendor All workstations used to process images must be validated, able to support the image file type generated by the gamma camera and able to perform the image reconstruction and analysis requirements detailed in Sections 3.7 and 3.10. Camera System Owned by imaging center; placed by technologist A camera system should be used that meets the requirements detailed under Image Data Acquisition in Section 3.6. This includes specific requirements for the collimator, projection bin (pixel) size, head-holder, etc. 3.2 INSTALLATION AND 3.2.2 trial
002.QIBA_SPECT_Profile_Checklist_Extract.2016_10_22.docx