Arietta 50
by Hitachi Healthcare Americas Corporation
510(k) K190248
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK190248 | Date2 Apr 2019 | 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- Withdrawn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
- FDA applicant
- Hitachi Healthcare Americas
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1550
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Arietta 50 is a diagnostic ultrasound system, designed for high-resolution imaging of internal body structures. It employs advanced transducer technology and real-time imaging capabilities to support radiologic evaluations, including abdominal, obstetric, gynecologic, and vascular assessments. This device integrates automated functions to enhance workflow efficiency while maintaining precision in diagnostic imaging.
The Arietta 50 is intended for use in radiology departments and clinical settings where ultrasound imaging is required. It is supplied as a reusable medical device and is cleared for use in the United States under FDA 510(k) clearance (K190248) through the Traditional pathway. The system adheres to Class II radiology device regulations and is not classified as MRI-safe or MRI-conditional. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and compliance with regulatory standards.
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Questions
AI-generated answers, 1 Oct 2026
What types of medical evaluations is the Arietta 50 ultrasound system designed for?
The Arietta 50 is specifically engineered for high-resolution imaging of internal structures, supporting evaluations in radiology departments. It is particularly suited for abdominal, obstetric, gynecologic, and vascular assessments, providing clear and detailed visualizations to aid in accurate diagnostic decisions.
Is the Arietta 50 a single-use or reusable device?
The Arietta 50 is a reusable medical device. Like other high-end ultrasound systems, it is built for repeated use in clinical settings, requiring proper maintenance and cleaning protocols to ensure reliability and compliance with regulatory standards.
What regulatory pathway was used for FDA clearance of the Arietta 50?
The Arietta 50 received FDA clearance through the Traditional 510(k) pathway, specifically under clearance number K190248. This pathway is used for devices deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards.
Does the Arietta 50 have any special safety considerations for MRI environments?
The Arietta 50 is not classified as MRI-safe or MRI-conditional. This means it should not be used in MRI environments, as its components may pose risks or interfere with MRI operations. Always follow manufacturer guidelines for safe device placement and usage.
How should the Arietta 50 be stored and maintained?
The Arietta 50 requires adherence to manufacturer-provided storage and maintenance guidelines to ensure optimal performance and longevity. Proper storage conditions, regular servicing, and cleaning protocols are essential to prevent malfunctions and maintain compliance with regulatory standards for reusable medical devices.