As of 7/27/2000 this document is obsolete as the ” Guidance for the Submission OfPremarket Notifications for Medical Image Management Devices” was issued to replace it. This remains on the site for historical reference and background only but SHOULD NOT BE USED FOR PREPARING FDA SUBMISSIONS.
AK
FDA CDRH’s Office of Device Evaluation’s second version of “Guidance for the Comment and Review of 510(k) Notifications for Picture Archiving and Communications Systems (PACS) and Related Devices” issued August 1, 1993. This version allowed for use of lossy compression. Medical devices.