(166 days)
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.