I3 System-Abd Diagnostic Ultrasound
by Ellex, Inc.
510(k) K103608
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK103608 | Date27 Dec 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IYO
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1560
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The I3 System ABD Diagnostic Ultrasound is a Class II diagnostic ultrasound system designed for abdominal imaging. It employs ultrasound technology to generate real-time visualizations of internal abdominal structures, aiding in the assessment of organs, tissues, and potential pathologies such as masses or fluid accumulations.
This device is intended for use in radiology settings by trained professionals. Supplied as a reusable system, it requires proper maintenance and calibration to ensure accurate imaging. The I3 System ABD Diagnostic Ultrasound holds FDA 510(k) clearance under K-number K103608, with a Special clearance type and is classified under the Radiology advisory committee. No specific sterility or MRI safety information is provided in the available data.
Other devices from Ellex, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of abdominal imaging can the I3 System ABD Diagnostic Ultrasound perform, and who is it intended for?
The I3 System ABD Diagnostic Ultrasound is specifically designed for abdominal imaging, allowing real-time visualization of internal structures such as organs, tissues, and potential abnormalities like masses or fluid accumulations. It is intended for use in radiology settings by trained professionals, such as radiologists or sonographers, who have the expertise to interpret ultrasound images.
Is the I3 System ABD Diagnostic Ultrasound a single-use or reusable device, and what maintenance is required?
The I3 System ABD Diagnostic Ultrasound is a reusable device, meaning it is designed for repeated use in clinical settings. Since it is reusable, it requires proper maintenance and regular calibration to ensure consistent and accurate imaging performance over time. This includes adherence to manufacturer guidelines for cleaning, servicing, and technical checks.
How was the FDA clearance for the I3 System ABD Diagnostic Ultrasound determined, and what does that mean for its regulatory status?
The I3 System ABD Diagnostic Ultrasound received FDA clearance through a 510(k) pathway, specifically under K-number K103608, with a classification as substantially equivalent (SESE) to a predicate device. The clearance was granted under a special type and falls under the Radiology advisory committee (RA). This means the device was evaluated and determined to be as safe and effective as legally marketed alternatives, ensuring it meets regulatory standards for diagnostic ultrasound systems in abdominal imaging.
What should I know about the storage or handling of the I3 System ABD Diagnostic Ultrasound?
The provided data does not specify storage conditions or handling instructions for the I3 System ABD Diagnostic Ultrasound itself, but as a reusable medical device, it should be stored in a clean, controlled environment to prevent contamination or damage. Follow the manufacturer’s guidelines for proper setup, maintenance, and storage to ensure optimal performance and longevity of the system.