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

K011224 is an FDA 510(k) premarket notification submitted by Advanced Technology Laboratories, Inc. for the device "HDI 5000 ULTRASOUND SYSTEM WITH ASSISTED BORDER DETECTION (ABD), XRES IMAGING, AND PANORAMIC MEASUREMENT CAPABILITY". The FDA issued a decision of Substantially Equivalent on May 4, 2001. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Advanced Technology Laboratories, Inc. has at least 10 other 510(k) clearances on record.