03

Dec

1998

FDA CDRH 510(k)Tomography Devices and Accessories

devicecenter, fda

0

“Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems”

This documenent was issued on December 3, 1998.

Section VII.D is on software. It provides an itemized list of information to be included in the submission. This list basically is the requirements listed in the current FDA software submission guidance which is also referenced in this section. It does not state a specific level of concern and leaves that to be defined by the manufacturer. In the list of information to be provided it emphasizes that a list of errors and bugs remaining in the device be provided with an explanation of how they were determined not to to effect safety and effectiveness including operating usage and human factors.

Sections VIII.B & VIIII. Device Description for SPECT Devices and PET systems has several explicit references to software. Including that the device description list of major components of the system and their purpose, including related interfacing software. IT fFurther requires descriptions of aqusition processing, and network software, instruction methods, filtering, processing software,and third party software, as well as descriptions of the software that is part of accessory devices; display monitors, hand held or wireless remote control units, and storage devices.

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