PARASCRIPT (R) ACCUDETECT (R)

Analyzer, Medical Image

FDA Premarket Approval P120004 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for parascript accudetect version 7. 0.

• Device: PARASCRIPT (R) ACCUDETECT (R)
• Classification Name: Analyzer, Medical Image
• Generic Name: Analyzer, Medical Image
• Applicant: PARASCRIPT, LLC
• Date Received: 2015-01-27
• Decision Date: 2015-10-16
• PMA: P120004
• Supplement: S001
• Product Code: MYN
• Advisory Committee: Radiology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• Expedited Review: No
• Combination Product: No
• Applicant Address: PARASCRIPT, LLC 6273 Monarch Park Place longmont, CO 80503

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