Identity
- Trade Name
- PARASCRIPT ACCUDETECT 6.1.0 FDA PMA
- Generic Name
- Analyzer, medical image FDA PMA
Identifiers
- PMA Number
- P120004 FDA PMA
- FDA Product Code
- MYN FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 892.2070 FDA PMA
- Regulation Number
- 892.2070 FDA PMA
- Advisory Committee
- Radiology FDA PMA
- FDA Decision
- APRL FDA PMA
The Parascript AccuDetect 6.1.0 is a medical image analyzer designed for use in radiology. Classified as a Class II device, it functions as an automated tool to assist radiologists in screening mammograms by identifying areas suspicious for breast cancer during initial image review.
This device is supplied as a software-based solution and operates within a radiology setting. It is intended for single-use in diagnostic workflows, though its regulatory status includes FDA approval under a Premarket Approval (PMA) application (P120004). No specific sterility or MRI safety information is provided in the data, and no reusable components are indicated. The device adheres to regulatory requirements outlined under 21 CFR 892.2070.
Frequently asked questions
What specific clinical task does the Parascript AccuDetect 6.1.0 assist radiologists with during mammogram screening?
The Parascript AccuDetect 6.1.0 is designed to assist radiologists by automatically identifying areas within screening mammograms that may be suspicious for breast cancer. It serves as a decision-support tool to flag these regions for further review after the initial read, helping to streamline the detection process in radiology workflows.
Is the Parascript AccuDetect 6.1.0 a reusable device, or is it intended for single-use in clinical settings?
The Parascript AccuDetect 6.1.0 is supplied as a software-based solution and is intended for single-use within diagnostic workflows. Since it operates digitally and does not involve physical components that require reprocessing, it aligns with a single-use model in radiology settings.
What regulatory pathway was followed for FDA approval of the Parascript AccuDetect 6.1.0, and what does this indicate about its classification?
The Parascript AccuDetect 6.1.0 underwent FDA approval through a Premarket Approval (PMA) application (P120004), which is a rigorous review process for higher-risk medical devices. This classification as a Class II device under 21 CFR 892.2070 confirms it is intended for use in screening mammography to assist radiologists in identifying suspicious areas for breast cancer.
How is the Parascript AccuDetect 6.1.0 supplied, and does it require any physical hardware beyond the software?
The Parascript AccuDetect 6.1.0 is supplied exclusively as a software-based solution and does not require additional physical hardware beyond the necessary computing infrastructure in a radiology setting. It integrates into existing systems to analyze mammogram images and flag suspicious regions for review.
Are there any specific storage or handling requirements for the Parascript AccuDetect 6.1.0 software, given its single-use nature?
Since the Parascript AccuDetect 6.1.0 is a software-based solution, its storage and handling primarily involve maintaining the integrity of the digital system it runs on. No specific sterility or physical storage requirements are mentioned, but standard IT practices for software licenses, updates, and system security should be followed to ensure reliable operation in radiology workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P120004 | Class II | Active |
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Manufacturer
- Manufacturer
- Parascript, LLC
Sources (1)
- FDA PMA P120004 24 fields · synced Sep 18, 2026