PARASCRIPT ACCUDETECT 6.1.0

Analyzer, Medical Image

FDA Premarket Approval P120004

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.

Pre-market Approval Supplement Details

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.

• Device: PARASCRIPT ACCUDETECT 6.1.0
• Classification Name: Analyzer, Medical Image
• Generic Name: Analyzer, Medical Image
• Applicant: PARASCRIPT, LLC
• Date Received: 2012-03-30
• Decision Date: 2013-08-22
• Notice Date: 2013-09-10
• PMA: P120004
• Supplement: S
• Product Code: MYN
• Docket Number: 13M-1017
• Advisory Committee: Radiology
• Expedited Review: No
• Combination Product: No
• Applicant Address: PARASCRIPT, LLC 6273 Monarch Park Place longmont, CO 80503
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P120004		Original Filing
S001	2015-01-27	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
M760ACCFFDM00161	P120004	000
M760ACCFFDM00170	P120004	001