Ois-Stand Alone Diagnostic Ultrasound System
by Optimal Imaging Systems, Inc.
510(k) K000034
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK000034 | Date24 Feb 2000 | 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- Withdrawn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
- IYN
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The OIS Stand Alone Diagnostic Ultrasound System is a standalone diagnostic ultrasound device designed for imaging internal body structures. It generates high-frequency sound waves to create real-time visual images of organs, tissues, and blood flow, aiding in the diagnosis of medical conditions such as pregnancy, vascular disorders, and abdominal pathologies.
This system is intended for use in clinical, diagnostic, and research settings and is supplied as a complete, self-contained unit. It has received FDA 510(k) clearance under the product code IYN (Diagnostic Ultrasound Systems) and is classified as a Class II device. The device is non-sterile and reusable, with no specific MRI safety classification noted in the available data.
Other devices from Optimal Imaging Systems, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of medical conditions can this ultrasound system help diagnose, and in what settings is it typically used?
The OIS Stand Alone Diagnostic Ultrasound System is designed to create real-time images of internal body structures, such as organs, tissues, and blood flow. It aids in diagnosing conditions like pregnancy, vascular disorders, and abdominal pathologies. This system is intended for use in clinical, diagnostic, and research environments where real-time imaging is required for accurate medical assessments.
Is this ultrasound system reusable, and if so, how should it be maintained?
Yes, the OIS Stand Alone Diagnostic Ultrasound System is non-sterile and reusable. Since it is a reusable device, proper maintenance and cleaning protocols must be followed as outlined in the manufacturer’s instructions to ensure optimal performance, safety, and longevity. This includes regular servicing, calibration, and adherence to any cleaning guidelines provided by Optimal Imaging Systems, Inc.
What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?
The OIS Stand Alone Diagnostic Ultrasound System received FDA clearance through a 510(k) submission, specifically under the product code IYN (Diagnostic Ultrasound Systems). The device is classified as a Class II medical device, which means it is subject to special controls to ensure its safety and effectiveness. The clearance was determined under the Radiology (RA) advisory committee and was granted as substantially equivalent to a predicate device.
How is this ultrasound system supplied, and is it a standalone unit?
The OIS Stand Alone Diagnostic Ultrasound System is supplied as a complete, self-contained unit, meaning it does not require additional external components to function. It is designed for standalone use in clinical, diagnostic, or research settings, allowing for flexibility in deployment without needing integration with other systems.
Does this device have any specific safety considerations related to MRI environments?
The available data does not specify an MRI safety classification for the OIS Stand Alone Diagnostic Ultrasound System. If used in or near an MRI environment, additional precautions should be taken as outlined in the manufacturer’s instructions to avoid interference or safety hazards, such as ensuring non-ferromagnetic materials are used and following proper protocols for electromagnetic compatibility.