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MRIaudioPREM1004

by Mriaudio

MRIaudioPREM1004 is a Class II device made by Mriaudio, cleared under FDA 510(k) K180100 on 14 Jun 2018 and listed in FDA GUDID since 31 Mar 2026 (UDI-DI B66910041), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K180100

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB66910041 UDI-DI Date31 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180100 Date14 Jun 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180100 decided 14 Jun 2018 Active
  • FDA GUDID UDI-DI B66910041 listed 31 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180100
  2. Listed FDA GUDID B66910041

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Patient audiovisual communication/entertainment system
Model / Ref / Catalog
1004
Primary DI / UDI-DI
B66910041
510(k) Number
FDA product code
LNH
GMDN term
Patient audiovisual communication/entertainment system
Device class
Class II
Regulation number
892.1000
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K180100)

and 8 more cleared under K180100

Similar devices

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

Other devices from Mriaudio

  • MRIaudioPREM1003

    Class II

  • 3G Transducer 101

    Class II

  • MRIaudioPREM1004 1005

    Class II

  • MRIaudio 1507

    Class II

See all devices from Mriaudio →

Properties

  • Lot / batch number
Other properties (14, all answered No)