(966 days)
ESI-1000, ESI-2000, ESI-3000, 128 XP, UM-9
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound imaging modalities.
No.
Explanation: The device description and intended use indicate it is an imaging system used for diagnosis, not for therapeutic purposes. It produces images for analysis rather than delivering treatment.
Yes
The device is described as an "ultrasound system" used for "2D imaging, spectral Doppler analysis, and color Doppler Imaging" in various medical specialties, which are all diagnostic functions.
No
The device description explicitly states it is a "multi function real time ultrasound imaging system" that uses "a variety of linear array, curved array, annular array, and mechanical sector probes," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use describes the device as an ultrasound system for imaging and analysis within the human body (general radiology, obstetrics/gynecology, cardiology, peripheral vessels). This is a diagnostic imaging device, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description confirms it's an ultrasound imaging system, which operates by transmitting and receiving sound waves to create images of internal structures. This is a non-invasive imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or performing tests on samples outside the body, which are the hallmarks of an IVD.
Therefore, the ESI-5000 ultrasound system is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler Imaging.
Product codes
Not Found
Device Description
It is a multi function real time ultrasound imaging system, featuring 2D imaging, M mode, Spectral Pulsed and CW Doppler, and Color Flow, using a variety of linear array, curved array, annular array, and mechanical sector probes, in the frequency range of 3.5 MHz. to 10 MHz.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ESI-1000, ESI-2000, ESI-3000, 128 XP, UM-9
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUN | 2 1996
SUMMARY.
The ESI-5000 ultrasound system main applications are in general radiology, obstetrics/gynecology, cardiology, and peripheral vessel 2D imaging, spectral Doppler analysis, and color Doppler Imaging.
It is a multi function real time ultrasound imaging system, featuring 2D imaging, M mode, Spectral Pulsed and CW Doppler, and Color Flow, using a variety of linear array, curved array, annular array, and mechanical sector probes, in the frequency range of 3.5 MHz. to 10 MHz.
Regarding safety and effectiveness, the main features of the ESI-5000 are compared to the main features of the following predicate ultrasound systems:
ESI-1000 manufactured by Elscint Ltd. ESI-2000 manufactured by Elscint Ltd. ESI-3000 manufactured by Elscint Ltd. 128 XP manufactured by Acuson.
UM-9 manufactured by ATL.
Acoustic output compliance:
Since the ESI-5000 includes "Fetal Doppler" examination capabilities, the ultrasound system-transducer combination conforms with the out put display standard, and is designed to comply with the maximum intensity levels for track 3:
The absolute maximum intensity is limited to SPTA=720 mW/cm2, and SPPA=190 W/cm2. In addition the intensity is limited to the operator selected, application specific limit, which is always below the allowed absolute maximum.