Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PARASCRIPT ACCUDETECT 6.1.0
• Generic Name: Analyzer, medical image
• Regulation Number: 892.2070
• Applicant: PARASCRIPT, LLC; 6273 MONARCH PARK PLACE; LONGMONT, CO 80503
• PMA Number: P120004
• Date Received: 03/30/2012
• Decision Date: 08/22/2013
• Reclassified Date: 02/21/2020
• Product Code: MYN
• Docket Number: 13M-1017
• Notice Date: 09/10/2013
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR THE PARASCRIPT® ACCUDETECT® 6.1.0. THIS DEVICE IS INDICATED FOR USE IN SCREENING MAMMOGRAPHY TO IDENTIFY AREAS SUSPICIOUS FOR BREAST CANCER FOR RADIOLOGIST REVIEW AFTER COMPLETING AN INITIAL READ.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001