FDA.reportPublic FDA data

PARASCRIPT, LLC

Matched from indexed company URL: Parascript, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096708423009670842PARASCRIPT, LLC1N2020-04-256273 Monarch Park Place Longmont CO US 80503

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
M760ACCFFDM00161Parascript® AccuDetect® - Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.888-772-7478customer.service@parascript.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1630122034482290P120004PARASCRIPT ACCUDETECT 6.1.0MYN2013-08-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MYN12013-08-22

PMA#

GUDID#

Parascript® AccuDetect® - Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.

PARASCRIPT, LLC

2016-02-29

Parascript® AccuDetect® - Parascript® AccuDetect® is a Computer-Aided Detection (CAD) software device intended to aid radiologists reading mammograms. It is a proprietary software application designed to process FFDM images. The digital mammography images are automatically analyzed to identify areas suspicious for possible soft tissue densities and/or calcifications. Results are displayed on a computer monitor for review by a radiologist. The radiologist is instructed to first review each case in the conventional manner and then re-examine the case utilizing the information supplied by the Parascript® AccuDetect system before making a final assessment for the case.AccuDetect® is not a diagnostic device, as the CAD marks are intended to be used to assist only in detection and not in interpretation. Therefore, AccuDetect® can assist a radiologist in detecting areas of concern that would have been missed without its use, but if used properly it cannot cause a radiologist to miss areas of concern that would have been detected without AccuDetect®.

PARASCRIPT, LLC

2015-05-04