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Parascript® AccuDetect®

FDA UDI

Class II (US FDA UDI)

by Parascript, LLC

Identity

Trade Name
Parascript® AccuDetect® FDA UDI
Generic Name
Radiology DICOM image processing application software FDA UDI
Device Name
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®. FDA UDI
Model / Reference
7.0 FDA UDI
Description
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®. FDA UDI

Identifiers

Catalog Number
ACCFFDM00170 FDA UDI
Primary DI / UDI-DI
M760ACCFFDM00170 FDA UDI
PMA Number
P120004 FDA UDI
FDA Product Code
MYN FDA UDI
GMDN Term
Radiology DICOM image processing application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Radiology DICOM image processing application software

Parascript® AccuDetect® by Parascript, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Radiology DICOM image processing application software.

Cleared under the same submission

P120004 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Parascript, LLC

Sources (1)

  • FDA UDI f6801c2f-9428-4b65-aa1c-f1b2cb6c27b0 35 fields · synced Jun 1, 2026