Devices · Hologic, Inc.

M1000 IMAGECHECKER

Hologic, Inc. is listed for M1000 IMAGECHECKER (P970058). The FDA list gives June 26, 1998 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the PMA pathway. openFDA describes product code MYN as “Analyzer, Medical Image”: For information on the MYN device, please see: https://www.federalregister.gov/documents/2020/01/22/2020-00494/radiology-devices-reclassification-of-medical-image-analyzers openFDA records decision code APRL for this submission. This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P970058

Official FDA database record

Date of final decision

June 26, 1998

Company on the FDA list

Hologic, Inc.

Lead panel

Radiology

Primary product code

MYN

openFDA device name for the code

Analyzer, Medical Image

Device class

2

Regulation number

892.2070

openFDA decision description

Not returned

openFDA decision code

APRL

Statement or summary label

Statement