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Silent Scan

by Avotec, Inc.

510(k) K921891

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK921891 Date13 May 1993ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Silent Scan MRI Audio System is a System, Nuclear Magnetic Resonance Imaging device designed to facilitate patient communication and audio monitoring within MRI environments. It mitigates interference from MRI electromagnetic fields, ensuring clear audio transmission for diagnostic and procedural purposes.

This system is intended for use in MRI facilities, providing MRI-compatible audio solutions with headset options for patient communication and monitoring. Supplied as a reusable device, it adheres to MRI safety standards and is regulated under FDA 510K clearance (K921891). Authorized for Class II medical devices under regulation number 892.1000, it requires proper handling and storage to maintain functionality.

Similar devices

Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).

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