Ai 5200 Diagnostic Ultrasound System W/Doppler
510(k) K893833
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK893833 | Date11 Sep 1989 | 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- Withdrawn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, 20 Sep 2026
The AI 5200 Diagnostic Ultrasound System with Doppler is a Class II medical imaging device designed for diagnostic radiology. It employs ultrasound technology to generate real-time images of internal body structures, including soft tissues and organs, while incorporating Doppler functionality to assess blood flow and vascular conditions. This system is intended for clinical use in radiology departments to aid in the evaluation of various anatomical and physiological parameters.
This device is supplied as a reusable, non-sterile Class II medical instrument and is intended for use in radiology settings. It has received FDA 510(k) clearance under K-number K893833, with a decision date of September 11, 1989. The system is regulated under the Product Code IYN and was reviewed by the Radiology (RA) Advisory Committee. No third-party review was involved, and it is not indicated for MRI use or sterile procedures.
Other devices from Acoustic Imaging
Questions
AI-generated answers, 20 Sep 2026
What types of medical evaluations can the AI 5200 Diagnostic Ultrasound System with Doppler assist with in a clinical setting?
The AI 5200 Diagnostic Ultrasound System with Doppler is designed to generate real-time images of internal body structures, such as soft tissues and organs, helping clinicians evaluate anatomical and physiological parameters. Its Doppler functionality specifically allows for the assessment of blood flow and vascular conditions, making it useful for diagnosing circulatory issues, organ perfusion, and other vascular-related concerns in radiology departments.
Is the AI 5200 Diagnostic Ultrasound System intended for single-use or reusable applications, and what does that mean for maintenance?
The AI 5200 Diagnostic Ultrasound System is supplied as a reusable device, meaning it is not intended for single-use. This implies that it must be properly cleaned, disinfected, and maintained between uses in accordance with established clinical protocols to ensure safety, functionality, and compliance with regulatory standards. Reusability also requires adherence to manufacturer guidelines for servicing and calibration.
How is the sterility of the AI 5200 Diagnostic Ultrasound System defined, and what does that imply for its use in procedures?
The AI 5200 Diagnostic Ultrasound System is explicitly labeled as non-sterile, meaning it is not intended for sterile procedures. This classification is important because it restricts its use to non-invasive diagnostic imaging in radiology settings where sterility is not required, such as general anatomical or vascular assessments. Sterile procedures, like surgeries, would require additional sterile equipment or disposables.
What regulatory pathway was followed for FDA clearance of the AI 5200 Diagnostic Ultrasound System, and who reviewed the submission?
The AI 5200 Diagnostic Ultrasound System received FDA clearance through a Traditional 510(k) review, determined to be substantially equivalent to a predicate device. The submission was reviewed by the Radiology (RA) Advisory Committee and was not subject to third-party review. The clearance was granted under Product Code IYN with a decision date of September 11, 1989.