FDA CDRH 510(k) Guidance for PACS – OBSOLETE

As of 7/27/2000 this document is obsolete as the ” Guidance for the Submission OfPremarket Notifications for Medical Image Management Devices” was issued to replace it. This remains on the site for historical reference and background only but SHOULD NOT BE USED FOR PREPARING FDA SUBMISSIONS.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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.