Modification To: Aurora
by Aurora Imaging Technology, Inc. 2 variants
510(k) K032678
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032678 | Date24 Sep 2003 | 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- Withdrawn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, 25 Sep 2026
The device is a Nuclear Magnetic Resonance Imaging System, classified as a Class II medical device. It is a modification to the Aurora system, intended for use in radiology for medical imaging purposes.
The device is supplied as a system and is regulated under FDA 510(k) clearance. It is not specified as single-use or reusable, and no information is provided regarding sterility, MRI safety, sizes, or storage conditions.
Other devices from Aurora Imaging Technology, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Aurora MRI system modification?
This is a Nuclear Magnetic Resonance Imaging system modification intended for radiology medical imaging purposes. It is a Class II medical device.
How is the device regulated?
The device is regulated under FDA 510(k) clearance. It is not specified as single-use or reusable, and no information is provided regarding sterility.
What is the device's regulatory status?
The device was reviewed and determined to be substantially equivalent to a predicate device. The review was conducted by the Radiology advisory committee.
What are the device's specifications?
The device is supplied as a system. No information is provided regarding sizes, storage conditions, or MRI safety.