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 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.
| Device | HDI 3000 ULTRASOUND SYSTEM |
| Generic Name | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. |
| Date Received | 1996-07-25 |
| Decision Date | 1996-12-23 |
| PMA | P940005 |
| Supplement | S001 |
| 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 |