| Note: 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. |
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| Device | HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD |
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| Generic Name | System, imaging, pulsed doppler, ultrasonic |
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| Regulation Number | 892.1550 |
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| Applicant | Advanced Technology Laboratories, Inc.
22100 Bothell Everett Hwy.
P.O. Box 3003
Bothell, WA 98041 |
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| PMA Number | P940005 |
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| Supplement Number | S002 |
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| Date Received | 05/30/1997 |
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| Decision Date | 07/21/1998 |
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| Withdrawal Date | 05/04/2009 |
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| Product Code |
IYN |
| Advisory Committee |
Radiology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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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. |
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