Fast Spin Echo
by Hitachi Medical Systems America, Inc. 2 variants
510(k) K935664
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK935664 | Date16 Mar 1994 | 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- Withdrawn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
- LNH
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.1000
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Fast Spin Echo MRI System is a nuclear magnetic resonance imaging device designed for radiologic imaging. It employs a fast spin echo sequence to acquire high-quality images of anatomical structures with improved efficiency and reduced artifacts compared to conventional spin echo techniques.
This system is intended for use in radiology departments within clinical settings and is supplied as a reusable medical device. It operates within MRI-safe environments and is regulated under FDA 510(k) clearance (K935664) as a Class II device, adhering to regulatory standards for nuclear magnetic resonance imaging systems. Multiple model references are associated with its regulatory submission.
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Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Fast Spin Echo MRI System, and how does it differ from conventional MRI techniques?
The Fast Spin Echo MRI System is designed for radiologic imaging to acquire high-quality images of anatomical structures more efficiently than conventional spin echo techniques. It uses a fast spin echo sequence to reduce imaging time and minimize artifacts, improving diagnostic clarity for radiologists in clinical settings.
Is the Fast Spin Echo MRI System intended for single-use or reusable applications, and what does this mean for maintenance?
The Fast Spin Echo MRI System is supplied as a reusable medical device, meaning it is built for repeated use within MRI-safe environments. This implies that it requires proper cleaning, calibration, and maintenance protocols to ensure consistent performance and compliance with regulatory standards over time.
How many model variants of the Fast Spin Echo MRI System are associated with its FDA submission, and does this indicate customization options?
The FDA submission lists multiple model references (over 100 unique FEI numbers) under the Fast Spin Echo MRI System, suggesting there are various configurations or variants available. However, these are regulatory identifiers tied to the device’s classification and submission process—not necessarily distinct clinical models with differing capabilities. Buyers should confirm specific model features with the manufacturer.
What regulatory pathway was followed for the Fast Spin Echo MRI System’s FDA clearance, and what does this imply for its safety and performance standards?
The Fast Spin Echo MRI System was cleared via the FDA 510(k) pathway under the Traditional Review process, with a decision of Substantially Equivalent (SE) to a predicate device. This means its safety and performance were determined to meet FDA standards for nuclear magnetic resonance imaging systems (Class II device) by demonstrating equivalence to an existing approved technology, ensuring it adheres to rigorous regulatory benchmarks.