This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
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.
| Device | HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD |
| Generic Name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| Date Received | 1997-05-30 |
| Decision Date | 1998-07-21 |
| PMA | P940005 |
| Supplement | S002 |
| Product Code | IYN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 Bothell Everett Hwy. p.o. Box 3003 bothell, WA 98041-3003 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940005 | Original Filing | |
| S002 | 1997-05-30 | Normal 180 Day Track |
| S001 | 1996-07-25 | Normal 180 Day Track |