MRIaudio 1507
by Mriaudio
MRIaudio 1507 is a Class II device made by Mriaudio, cleared under FDA 510(k) K180100 on 14 Jun 2018 and listed in FDA GUDID since 3 Mar 2026 (UDI-DI B66915070), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB66915070 | Date3 Mar 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180100 | Date14 Jun 2018 | StatusActive |
Official records
- FDA 510(k) database K180100
Across registries
- FDA 510(k) K180100 decided 14 Jun 2018 Active
- FDA GUDID UDI-DI B66915070 listed 3 Mar 2026 Listed
Timeline
- Cleared FDA 510(k) K180100
- Listed FDA GUDID B66915070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MRIaudio
- Generic name
- Patient audiovisual communication/entertainment system
- Model / Ref / Catalog
- 1507
- Primary DI / UDI-DI
- B66915070
- 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
Similar devices
Other devices filed under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging).
- SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM by General Electric Co.
- MRT 35-A (TM) by Toshiba America Mri, Inc.
- EMMA 1.5T MRI System by Time Medical Limited
- CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT by SIEMENS MEDICAL SOLUTIONS USA, INC.
- MultiBand SENSE by Philips Medical Systems Nethrlands BV
- MrOpen by Paramed S.R.L.
- VISTA MR 2055 HP SYSTEM by Philips Medical Systems (Cleveland), Inc.
- VANTAGE TITAN, MODEL MRT-1504/S3 by Toshiba America Medical Systems, In.C
- MAGNETOM AERA; MAGNETOM SKYRA by SIEMENS MEDICAL SOLUTIONS USA, INC.
- MODEL #510GE1500 LIVER ARRAY COIL by Medic, Inc.