HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
FDA 510(k) clearance K011224 · decided 2001-05-04
Clearance details
- K-number
- K011224
- Device name
- HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY
- Applicant
- Advanced Technology Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-20
- Decision date
- 2001-05-04
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bothell, WA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD (P940005/S002) | Advanced Technology Laboratories, Inc. | 1998-07-21 |
| HDI 3000 ULTRASOUND SYSTEM (P940005/S001) | Advanced Technology Laboratories, Inc. | 1996-12-23 |
| ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM (P940005) | Advanced Technology Laboratories, Inc. | 1996-04-11 |