(167 days)
ARIETTA Precision is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal (Includes imaging for guidance of percutaneous biopsy of abdominal organs and structures (including amniocentesis.), Intra-operative (Includes imaging of organs and structures exposed during surgery (excluding neurosurgery and laparoscopic procedures.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Includes thyroid, parathyroid, breast, scrotum, penis and imaging for guidance of biopsy .), Neonatal Cephalic, Adult Cephalic, Trans-rectal (Includes imaging for guidance of trans-rectal biopsy.), Trans-vaginal (Includes imaging for guidance of trans-vaginal biopsy.), Trans-esophageal (non-Cardiac - Adult/Pediatric), Musculo-skel. (Convent), Musculo-skel. (Superfic.), Other (spec.) -Wound (Includes imaging for Cavernous/Non-Cavernous wounds.), Other (spec) - Gynecological, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac - Adult/Pediatric) and Peripheral vessel clinical applications.
The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography) and TDI (Tissue Doppler Imaging), Trapezoid mode, Free Angular M mode.
The ARIETTA Precision is a compact ultrasound device that can be used by the patient bedside. Similar to the predicate: Arietta 70 cleared via K134016; the ARIETTA Precision is considered a "point of care" system that provides flexibility for patient scanning in any environment.
This instrument can be used for individual or combined display in the image display modes listed below.
- B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above.
- M mode is a display mode of ultrasound beams received sequentially and repeatedly on the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
- There are two types of D (Doppler) mode and CW Doppler mode. PW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
- Color Doppler mode receives ultrasound from the same direction and detects any changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.
The 5 methods of electronic scanning available on the ARIETTA Precision include:
- Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
- Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
- Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.
- Radial Scanning Method: By this method, the ultrasound probe emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject ..
- Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the test subject.
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§ 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.