• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 
Trade NamePARASCRIPT ACCUDETECT 6.1.0
Classification Nameanalyzer,medical image
ApplicantPARASCRIPT, LLC
PMA NumberP120004
Date Received03/30/2012
Decision Date08/22/2013
Product Code
MYN[ Registered Establishments with MYN ]
Docket Number 13M-1017
Notice Date 09/10/2013
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
-
-