PMA P940005S002

Device: HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD
Applicant: Advanced Technology Laboratories, Inc.
PMA number: P940005
Supplement: S002
Product code: IYN
Decision date: 1998-07-21
Generic name: System, imaging, pulsed doppler, ultrasonic
Approval order statement: Approval for design change from HDI 3000(R) Ultrasound System with L10-5 Scanhead to HDI 3000(R) Ultrasound System with L12-5 Scanhead for the indication of an adjunct o mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utlity of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies perofrmed on indeterminate lesions.

Current openFDA PMA Record#

Device: HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD
Applicant: Advanced Technology Laboratories, Inc.
PMA number: P940005
Supplement: S002
Product code: IYN
Generic name: System, imaging, pulsed doppler, ultrasonic
Decision date: 1998-07-21
Decision code: APPR
Date received: 1997-05-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for design change from HDI 3000(R) Ultrasound System with L10-5 Scanhead to HDI 3000(R) Ultrasound System with L12-5 Scanhead for the indication of an adjunct o mammography and physical breast examination, to provide a high degree of physician confidence in differentiating benign from malignant or suspicious breast lesions. This device provides the physician with additional information to guide a biopsy decision. Utlity of this system has been demonstrated for lesions with an indeterminate Level of Suspicion (LOS 2-4) by conventional diagnostic modalities. Using the HDI system in the evaluation of solid mass characteristics can reduce the number of biopsies perofrmed on indeterminate lesions.