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Innovision 00

by Innovere Medical, Inc.

Innovision 00 is a Class II device made by Innovere Medical, Inc., cleared under FDA 510(k) K193218 on 7 Apr 2020 and listed in FDA GUDID since 22 Feb 2021 (UDI-DI 00628176432212), 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) K193218

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 Number00628176432212 UDI-DI Date22 Feb 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193218 Date7 Apr 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193218 decided 7 Apr 2020 Active
  • FDA GUDID UDI-DI 00628176432212 listed 22 Feb 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193218
  2. Listed FDA GUDID 00628176432212

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Innovision
Generic name
Patient audiovisual communication/entertainment system
Model / Ref / Catalog
00
Primary DI / UDI-DI
00628176432212
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

Category: Patient audiovisual communication/entertainment system

Similar devices

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

Other devices from Innovere Medical, Inc.

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (10, all answered No)