NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil
510(k) K042103
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042103 | Date16 Aug 2004 | 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- Withdrawn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
- MOS
- 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 NVA-63-8-A and NVA-63-16-A Neurovascular Array Coil is a Coil, Magnetic Resonance, Specialty designed for neurovascular imaging. It functions as a radiofrequency (RF) receiver coil, capturing RF signals emitted from the patient’s head and neck during MRI procedures to enhance image quality and detail in vascular structures.
This device is intended for use in clinical radiology settings with MRI scanners. Supplied as a reusable, non-sterile component, it requires compliance with MRI safety standards and is authorised under FDA 510(k) clearance (K042103). The coils are supplied in configurations of eight and sixteen elements, each tailored for high-resolution neurovascular imaging, and must be stored and handled according to manufacturer guidelines to maintain performance.