MRIview 3000

MRIview 3000 is a Class II device made by Mriaudio, cleared under FDA 510(k) K193102 on 6 Jan 2020 and listed in FDA GUDID since 10 Jan 2020 (UDI-DI B66930001), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberB66930001 UDI-DI	Date10 Jan 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK193102	Date6 Jan 2020Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K193102

Across registries

2 registries list this device

FDA 510(k) K193102 decided 6 Jan 2020 Active
FDA GUDID UDI-DI B66930001 listed 10 Jan 2020 Listed

Timeline

2 dated events

6 Jan 2020 Cleared FDA 510(k) K193102
10 Jan 2020 Listed FDA GUDID B66930001

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: MRIview
Generic name: Patient audiovisual communication/entertainment system
Model / Ref / Catalog: 3000

Primary DI / UDI-DI: B66930001
510(k) Number: K193102
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

Other devices from Mriaudio

See all devices from Mriaudio →

Properties

Lot / batch number

Other properties (14, all answered No)