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As of 7/27/2000 this document is obsolete as the ” Guidance for the Submission OfPremarket Notifications for Medical Image Management Devices” was issued to replace it. This remains on the site for historical reference and background only but SHOULD NOT BE USED FOR PREPARING FDA SUBMISSIONS.

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.

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020
Registration Link

Receive $300 discount with Premium-Individual subscription purchase (or $333 per person for Premium-Company subscription)!  Email training@softwarecpr.com
to receive discount

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020
For info on this course, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.