The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Hdi 5000 Ultrasound System With Assisted Border Detection (abd), Xres Imaging, And Panoramic Measurement Capability.
| Device ID | K011224 |
| 510k Number | K011224 |
| Device Name: | HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Mark Job TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-04-20 |
| Decision Date | 2001-05-04 |