(604 days)
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No
The description focuses on standard ultrasound technology and operating modes, with no mention of AI or ML features.
No
The device is described as a "diagnostic ultrasound system" and its indicated uses are for various types of imaging, which are diagnostic in nature, not therapeutic.
Yes
The device description explicitly states it is a "Track 3 diagnostic ultrasound system."
No
The device description explicitly states it is an "Ultrasound Electronic Scanner" and describes hardware components like "digital front-end electronics" and "probes."
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- The description clearly states the Hitachi EUB-8000 is an Ultrasound Electronic Scanner. Ultrasound is an imaging modality that uses sound waves to create images of structures inside the body.
The description of the device's function and intended uses (imaging various anatomical sites) confirms it is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The Hitachi EUB-8000 Ultrasound Electronic Scanner is a Track 3 diagnostic ultrasound system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler. Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative , Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transvaginal, Transvaginal, and Neonatal Cephalic. The EUB-8000 utilizes digital front-end electronics for detection of echo signals.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral Vascular, Transvaginal, Neonatal Cephalic
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
Revised April 28, 1997
MAY-7-1997
ATTACHMENT 11
SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-8000 Ultrasound Electronic Scanner
Device Description
The Hitachi EUB-8000 Ultrasound Electronic Scanner is a Track 3 diagnostic ultrasound system capable of the following operating modes: B, M, Pulsed Doppler, Color Flow, and Continuous Wave Doppler. Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative , Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transvaginal, Transvaginal, and Neonatal Cephalic. The EUB-8000 utilizes digital front-end electronics for detection of echo signals.
Safety
As a Track 3 ultrasound system, the Hitachi EUB-8000 Ultrasound Electronic Scanner complies with the "Standard for Real-time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment (1992), published by the National Electrical Manufacturers Association as UD-3. With respect to limits on acoustic outputs, the Hitachi EUB-8000 Ultrasound Electronic Scanner complies with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance.
With regard to general safety, the Hitachi EUB-8000 Ultrasound Electronic Scanner will be designed to comply with the IEC 601-1 (1988) Medical Electrical Equipment, Part 1, General Requirements for Safety.