(205 days)
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No
The summary describes standard ultrasound technology and image processing without mentioning AI, ML, or related concepts.
No
The device is described as an imaging tool used to aid in the diagnosis of disease, processing reflected sound waves into an image. It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for imaging body structures to aid in the diagnosis of disease or abnormality." Additionally, the "Device Description" mentions it functions in the same manner as "other diagnostic ultrasound devices."
No
The device description explicitly mentions a "piezo-electric transducer" which is a hardware component used to transmit and receive ultrasound waves. This indicates it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "imaging body structures to aid in the diagnosis of disease or abnormality." This describes an in vivo imaging process, where the device interacts directly with the patient's body to produce images.
- Device Description: The description clearly outlines how the device uses ultrasound waves transmitted into the body and reflected back from tissues to create images. This is the fundamental principle of diagnostic ultrasound, which is an in vivo imaging modality.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not examine specimens in vitro.
The device is a diagnostic ultrasound system, which is a type of medical imaging device used in vivo.
N/A
Intended Use / Indications for Use
The Aloka SSD-1700, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
Product codes
90 IYN, 90 IYO, 90 ITX
Device Description
The Aloka SSD-1700 diagnostic ultrasound system and associated transducers. The Aloka SSD-1700 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into an image. The Aloka SSD-1700 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow. The Aloka SSD-1700 diagnostic ultrasound system with gray-scale and Doppler imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
Body structures
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)
Aloka Omniview diagnostic ultrasound system
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
R -3 1997
510(k) SUMMARY 1.
This summary statement complies with 21 CFR, section 807.92 as amended March 14, l 995 :
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka SSD-1700 diagnostic ultrasound system and associated transducers. The address is:
10 Fairfield Boulevard Wallingford, CT. 06492
The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.
The proprietary name is the Aloka SSD-1700 diagnostic ultrasound system. The common name for this type of device is a diagnostic ultrasound system.
The items in this submission are covered under the following classifications:
90 IYN - System, Imaging, Pulsed Doppler, Ultrasonic 90 IYO - System, Imaging, Pulsed Echo, Ultrasonic 90 ITX - Transducer, Ultrasonic, Diagnostic
The above as stated in 21 CFR, part 892.1550, 892.1560 and 892.1570, have been classified as regulatory Class II.
The Aloka SSD-1700 is substantially equivalent to the Aloka Omniview diagnostic ultrasound system and transducers. The Aloka Omniview was originally cleared for market via the 510(k) process in 1996.
The Aloka SSD-1700 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is processed into an image. The Aloka SSD-1700 can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka SSD-1700, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
1
The Aloka SSD-1700 diagnostic ultrasound system with gray-scale and Doppler imaging modalities is similar in technological characteristics to ultrasound systems marketed by Aloka and others:
- The SSD-1700 is indicated for the same diagnostic ultrasound applications as other • products currently marketed by ALOKA and others.
- The SSD-1700 has the same gray-scale and Doppler abilities as other products . currently offered by ALOKA and others.
- The SSD-1700 uses essentially the same technologies for imaging, Doppler functions . and signal processing as other products currently marketed by ALOKA and others.
- The SSD-1700 has the same method of use as other products currently marketed by . ALOKA and others.
- The SSD-1700 acoustic power output levels are below the maximum levels allowed . by the FDA.
- The SSD-1700 is subjected to the same Quality Assurance systems in development . and production as other products currently marketed by ALOKA.
- The patient contact materials used in the probes for the SSD-1700 are the same as . those currently used in probes for other ultrasound systems currently marketed by ALOKA. These materials have been evaluated and found to be safe for this application.
- The SSD-1700 complies with the same electrical and physical safety standards as . other products currently marketed by ALOKA.
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