PMA P940005S001

Device: HDI 3000 ULTRASOUND SYSTEM
Applicant: Advanced Technology Laboratories, Inc.
PMA number: P940005
Supplement: S001
Product code: IYN
Decision date: 1996-12-23
Generic name: System, imaging, pulsed doppler, ultrasonic
Approval order statement: APPROVAL FOR A DESIGN CHANGE FROM THE ULTRAMARK(R) 9 ULTRASOUND SYSTEM WITH HIGH DEFINITION(TM) IMAGING (HDI(TM)) AND L10-5 SCANHEAD TO A HDI 3000(R) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD FOR THE INDICATION OF AN ADJUNCT TO MAMMOGRAPHY AND PHYSICAL BREAST EXAMINATION, TO PROVIDE A HIGH DEGREE OF PHYSICIAN CONFIDENCE IN DIFFERENTIATING BENIGN FROM MALIGNANT OR SUSPICIOUS BREAST LESIONS.

Current openFDA PMA Record#

Device: HDI 3000 ULTRASOUND SYSTEM
Applicant: Advanced Technology Laboratories, Inc.
PMA number: P940005
Supplement: S001
Product code: IYN
Generic name: System, imaging, pulsed doppler, ultrasonic
Decision date: 1996-12-23
Decision code: APPR
Date received: 1996-07-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A DESIGN CHANGE FROM THE ULTRAMARK(R) 9 ULTRASOUND SYSTEM WITH HIGH DEFINITION(TM) IMAGING (HDI(TM)) AND L10-5 SCANHEAD TO A HDI 3000(R) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD FOR THE INDICATION OF AN ADJUNCT TO MAMMOGRAPHY AND PHYSICAL BREAST EXAMINATION, TO PROVIDE A HIGH DEGREE OF PHYSICIAN CONFIDENCE IN DIFFERENTIATING BENIGN FROM MALIGNANT OR SUSPICIOUS BREAST LESIONS.