HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD
FDA premarket approval P940005/S002 · decided 1998-07-21
Approval details
- PMA number
- P940005
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Days to decision
- 417 days
- Decision code
- APPR
- Product code
- IYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bothell, WA
- 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 indetermin
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Q LAB SOFTWARE (K021966) | Advanced Technology Laboratories, Inc. | 2002-07-02 |
| HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY (K011224) | Advanced Technology Laboratories, Inc. | 2001-05-04 |
| MEDLINK DIAGNOSTIC OFFLINE WORKSTATION (K002144) | Advanced Technology Laboratories, Inc. | 2000-09-28 |
| ULTRAMARK 400C/SONOACE 6000 ULTRASOUND SYSTEM (K992470) | Advanced Technology Laboratories, Inc. | 1999-08-23 |
| HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM (K991671) | Advanced Technology Laboratories, Inc. | 1999-06-18 |
| LEVEL 10 HDI (K961459) | Advanced Technology Laboratories, Inc. | 1997-03-26 |
| PEGASUS (K935009) | Advanced Technology Laboratories, Inc. | 1994-10-11 |
| NOVA MICROSONICS ACCESS IMAGE MANAGEMENT NETWORK/ACCESS ACQUISITION MODULE (K940423) | Advanced Technology Laboratories, Inc. | 1994-07-29 |