(30 days)
Not Found
Not Found
No
The summary describes a standard diagnostic ultrasound system and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic ultrasound system" and its probes are intended for "general clinical uses" which are all diagnostic in nature (e.g., Abdominal, Cardiac, Fetal). There is no mention of treating or preventing diseases or conditions.
Yes
The device is described as a "diagnostic ultrasound system," and its probes are intended for various "general clinical uses" for internal anatomical sites, indicating its role in diagnosis.
No
The device description explicitly states it is an "Ultrasound Electronic Scanner" and mentions "Probes available with the EUB-905," indicating it is a hardware device with associated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The description clearly states that the Hitachi EUB-905 is an Ultrasound Electronic Scanner. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
- Intended Use/Indications for Use: While this section is "Not Found," the listed clinical uses (Abdominal, Cardiac, Fetal, etc.) are all applications of medical imaging, not in vitro testing.
Therefore, the Hitachi EUB-905 is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Hitachi EUB-905 Ultrasound Electronic Scanner June 29, 1996
Attachment 11 Page 1
ATTACHMENT 11
SUMMARY OF SAFETY AND EFFECTIVENESS Hitachi EUB-905 Ultrasound Electronic Scanner
Device Description
The Hitachi EUB-905 Ultrasound Electronic Scanner is Track1 diagnostic ultrasound system capable of the following operating modes: B, B/M and M mode. Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intraoperative, Fetal, Pediatric, Small organ, Peripheral Vascular, Transrectal and Transvaginal.
Safety
With respect to limits on acoustic outputs, the Hitachi EUB-905 Ultrasound Electronic Scanner comply with the guideline limits set in the April 14, 1994, Revision of 510(k) Diagnostic Ultrasound Guidance as a Track1 ultrasound system.
With regard to general safety, the Hitachi EUB-905 Ultrasound Electronic Scanner is designed to comply with the international standards IEC 601-1 (1988) Medical Electrical Equipment, Part1, General Requirements for Safety.