Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3T

by Imris, Inc. 510(k)

Active United States

510(k) K123091

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK123091	Date27 Dec 2012Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K123091
FDA Product Code: MOS

Device Class: Class II
Regulation: 21 CFR Part 892.1000
Advisory Committee: Radiology
FDA Decision: SESE Substantially Equivalent

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