ImageChecker M1000 System

No FDA recalls found in the data synced 6 Oct 2026.

Trade name

M1000 Imagechecker

Generic name

Analyzer, medical image

PMA number

P970058 ↗

FDA product code

MYN

Device class

Class II

Regulation

21 CFR Part 892.2070

Advisory committee

Radiology

FDA decision

APRL

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• What clinical role does the ImageChecker M1000 System play in mammography workflows and how does it assist radiologists?

  The ImageChecker M1000 System is a computer-based tool designed to assist radiologists by analyzing digital mammographic images and identifying regions of interest that may have been overlooked during the initial review. It marks these areas to flag them for a second look, helping to reduce observational errors and improve diagnostic accuracy in screening mammograms.

• Is the ImageChecker M1000 System reusable or single-use, and what are the storage requirements?

  The ImageChecker M1000 System is a standalone computer-based device and is not intended for reuse in the traditional sense (e.g., sterilization). Since it is a software-integrated system, it does not require sterilization or single-use packaging. Proper storage involves maintaining the hardware in a clean, controlled environment to prevent dust or damage, ensuring software updates are applied as recommended by the manufacturer.

• What regulatory pathway was followed for the approval of the ImageChecker M1000 System, and what does this mean for its use?

  The ImageChecker M1000 System was authorized through the FDA’s Premarket Approval (PMA) process, specifically under PMA P970058. This means the device underwent rigorous review by the FDA to ensure its safety and effectiveness for its intended use—assisting radiologists in screening mammograms by identifying potential areas of concern in digital images. Clinicians can rely on this approval as evidence of the system’s validated performance.

• How is the ImageChecker M1000 System supplied, and what types of digital mammographic images is it compatible with?

  The ImageChecker M1000 System is supplied as a standalone computer system, meaning it comes pre-installed with the necessary software and hardware to operate independently within radiology settings. It is specifically designed to work with digital mammographic images, as outlined in its intended use, and is not compatible with analog or non-digital imaging formats.

• What are the key specifications or identifiers for the ImageChecker M1000 System in regulatory databases?

  The ImageChecker M1000 System is classified under the FDA’s product code MYN and is listed in OpenFDA with multiple registration numbers (e.g., 3017840913, 3024891354, etc.), reflecting its various configurations or software versions. It falls under the Radiology advisory committee (RA) and is categorized as a Class II medical device, indicating moderate regulatory oversight. These identifiers help track its compliance and submission history.