Serial Numbers: 5007750, 5008004, 5007734,5007742, 5007596, and50074277

Radiology Devices

2

No

Worldwide Distribution - US to TX, FL, and MA. Internationally to Australia

BK Medical ApS Ultrasound System Scanner bk2300 - || Model #: bk3500 with software releases 1.2.0, 1.2.1 and 1.2.2. || The system is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body, data processing and guidance of puncture and biopsy. The system performs simple geometric measurements and calculations in the following areas: Emergency Medicine, Anesthesia, MSK, Vascular, Cardiology, OB/GYN

Ultrasonics

Ultrasonics

All lot numbers

Nationwide Distribution --- including states of AR, CA, CO, CT, IL,IN, OK. OH, MA, MS, MD, NC, and NY.

Single-use sterile puncture attachment UA1256-U used with the BK Medical Ultrasounds: || Diagnostic Ultrasound scanner Pro Focus 2202 and Diagnostic Ultrasound Transducer 8667 Diagnostic Ultrasound scanner 2102 and Diagnostic Ultrasound Transducer 8667 || Diagnostic Ultrasound scanner 2101 and Diagnostic Ultrasound Transducer 8667 || Performing ultrasound guided biopsies of the prostate.