PMA · Radiology

M1000 IMAGECHECKER

by Hologic, Inc.

M1000 IMAGECHECKER is an AI-enabled medical device from Hologic, Inc. that the U.S. FDA approved through PMA P970058 on June 26, 1998. Its lead review panel is Radiology and its primary product code is MYN.

See also top radiology AI devices.

Key facts

Submission numberP970058
PathwayPMA
Date of final decision
Company (FDA list)Hologic, Inc.
Lead review panelRadiology
Primary product codeMYN

Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.

What this means

Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. M1000 IMAGECHECKER went through this pathway (P970058).

Product code MYN covers 43 devices on the FDA AI list. By decision date, this device is #1 of 43 under that code. Hologic, Inc. has 9 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

Similar devices (product code MYN)

More from Hologic, Inc.