PMA P010025S009

Device: HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Hologic, Inc.
PMA number: P010025
Supplement: S009
Product code: MUE
Decision date: 2007-01-17
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.

Current openFDA PMA Record#

Device: HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant: Hologic, Inc.
PMA number: P010025
Supplement: S009
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2007-01-17
Decision code: APPR
Date received: 2006-11-24
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MOUNTING HOLOGIC SECURVIEW REFERENCE IMAGE VIEWER INTO THE SELENIA ACQUISITION WORKSTATION (AWS) CABINET FOR RETRIEVING AND DISPLAYING PATIENT?S PRIOR IMAGES BUT NOT FOR PRIMARY IMAGE DIAGNOSIS.