510(k) K011224
HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY by
Advanced Technology Laboratories, Inc.
— Product Code IYN
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2001
- Date Received
- April 20, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type