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MRIaudio PREM System

by Mriaudio

510(k) K180100

MRIaudio PREM System is a Class II device made by Mriaudio, cleared under FDA 510(k) K180100 on 14 Jun 2018, active as of 22 Oct 2026.

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 NumberK180100 Date14 Jun 2018ClearedStatusActive

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  • Withdrawn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

cited in the FDA summary

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

Cites

Cited by

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

Devices cleared under K180100

18 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K180100
UDI-DISize and differences
3G Transducer 101
Mriaudio
101 / 101B6691011
Single use: no
No longer on the market
3G Transducer 101
Mriaudio
101 / 101B6691010
Single use: no
On the market
MRIaudio 1507
Mriaudio
1507 / 1507B66915070
Single use: no
On the market
MRIaudio Ear-Tip 302
Mriaudio
302 / 302B6693020
Single use: yes
On the market
MRIaudio Over-Ear Headphones 330
Mriaudio
330 / 330B6693301
Single use: no
No longer on the market
MRIaudio Over-Ear Headphones 330
Mriaudio
330 / 330B6693300
Single use: no
On the market
MRIaudio Siemens System SMNS0001
Mriaudio
SMNS0001 / SMNS0001B669SMNS00011
Single use: no
On the market
MRIaudio1400
Mriaudio
1400 / 1400B66914001
Single use: no
On the market
MRIaudio1505
Mriaudio
1505 / 1505B66915051
Single use: no
On the market
MRIaudio1506
Mriaudio
1506 / 1506B66915061
Single use: no
On the market
MRIaudio1600
Mriaudio
1600 / 1600B66916001
Single use: no
On the market
MRIaudioPREM1000
Mriaudio
1000 / 1000B66910001
Single use: no
On the market
MRIaudioPREM1001
Mriaudio
1001 / 1001B66910011
Single use: no
On the market
MRIaudioPREM1002
Mriaudio
1002 / 1002B66910021
Single use: no
On the market
MRIaudioPREM1003
Mriaudio
1003 / 1003B66910031
Single use: no
On the market
MRIaudioPREM1004
Mriaudio
1004 / 1004B66910041
Single use: no
On the market
MRIaudioPREM1004 1005
Mriaudio
1005 / 1005B66910051
Single use: no
On the market
Wishbone Headset 320
Mriaudio
320 / 320B6693201
Single use: no
On the market

Similar devices

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

Other devices from Mriaudio

  • MRIaudioPREM1003

    Class II

  • MRIaudioPREM1004

    Class II

  • 3G Transducer 101

    Class II

  • MRIaudioPREM1004 1005

    Class II

See all devices from Mriaudio →