Ra-I
by Diasonics, Inc. 510(k)
Active
510(k) K781642
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781642 | Date10 Oct 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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, 20 Sep 2026
The RA-I is a diagnostic ultrasound imaging system, classified under the product code IYN (Ultrasound Imaging Systems) by the FDA. It is designed for radiologic examination, enabling real-time visualization of internal body structures using high-frequency sound waves. This device supports imaging applications in various clinical settings, including general radiology and diagnostic evaluations. Its functionality aligns with traditional ultrasound systems of its era, providing essential diagnostic capabilities for physicians.
The RA-I is supplied as a reusable medical device intended for use in radiology departments within healthcare facilities. It was cleared for commercial distribution in the United States under the FDA’s 510(k) pathway, with clearance granted on October 10, 1978 (K781642). No specific sterility or single-use designation is noted in the regulatory data, though typical ultrasound systems of this period were non-sterile and required maintenance. The device’s specifications do not mention MRI safety or size variations, relying on the original manufacturer’s documentation for operational details.
Other devices from Diasonics, Inc.
Questions
AI-generated answers, 20 Sep 2026
Is the RA-I ultrasound system designed for single-use or is it meant to be reused in a clinical setting?
The RA-I is classified as a reusable medical device, intended for use in radiology departments within healthcare facilities. Since it was cleared under the FDA’s 510(k) pathway in 1978, it follows the typical maintenance and cleaning protocols expected for ultrasound systems of that era, rather than being intended for single-use.
What types of clinical evaluations or examinations is the RA-I primarily used for?
The RA-I is designed for radiologic examination, enabling real-time visualization of internal body structures using high-frequency sound waves. It supports general radiology and diagnostic evaluations, providing essential imaging capabilities for physicians in clinical settings.
How was the RA-I’s regulatory clearance process handled, and what does the product code IYN indicate?
The RA-I was cleared for commercial distribution in the U.S. through the FDA’s 510(k) pathway, specifically under the product code IYN, which categorizes it as an *Ultrasound Imaging System*. The clearance was granted on October 10, 1978, after a traditional review process by the Radiology (RA) Advisory Committee, confirming its substantial equivalence to prior devices.
Does the RA-I have any documented specifications regarding MRI compatibility or available probe sizes?
The provided regulatory data does not mention MRI safety or specific probe sizes for the RA-I. Operational details, including probe variations or MRI compatibility, would require reference to the original manufacturer’s documentation from Diasonics, Inc., as these aspects were not explicitly noted in the FDA submission.