HDI 3000 ULTRASOUND SYSTEM
FDA premarket approval P940005/S001 · decided 1996-12-23
Approval details
- PMA number
- P940005
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 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
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- IYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bothell, WA
- Statement
- 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.
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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 |