Guidance for the Content and Review of 510(k) Notification for Picture Archiving and the Communications Systems (PACS) and Related Devices. 03/27/95. Regulation Number: 21 CFR 892.2050, Product Code: LLZ

These Picture Archiving and Communication Systems (PACS) viewers are passive viewing systems having no hardware components. Images are sourced from other databases and are presented by PACS systems in various media.


Compliance Consultants has submitted many picture archiving and communications systems (PACS) from large scale databases to surgical planning and referral tools. Often these systems can run on compact platforms such as smart phones when workstations are not available.