Search Results

Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows: General (Track I only), Specific (Tracks I & III) including Ophthalmic, Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-urethral, Trans esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Intra-luminal, Other (spec.), Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Other (spec.), Peripheral vessel, Other (spec.).

The Hitachi EUB-5500 Diagnostic Ultrasound Scanner is a Track 3 Diagnostic Ultrasound Pulsed Doppler and Pulsed Echo Imaging System capable of the following operating functions: B Mode, M Mode, Pulsed Doppler Color Flow, Continuous Wave Doppler, Amplitude Doppler, Harmonic imaging, Superficial musculoskeletal imaging, 3D imaging, 4D imaging.

I am sorry, but the provided text only contains an FDA 510(k) premarket notification for the Hitachi EUB-5500 Diagnostic Ultrasound Scanner. It details the device description, safety compliance, and intended uses for various transducers.

The document does not describe any acceptance criteria for device performance, nor does it present any study or data proving the device meets acceptance criteria. It is primarily a regulatory filing for substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance, as it is not present in the given text.

Ask a specific question about this device