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JointVue 3D Echo 1.0

by Jointvue, LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850014885007 UDI-DI Date31 Jan 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
JointVue 3D Echo
Generic Name
Ultrasound imaging system operation software
Model / Reference
1.0
Primary DI / UDI-DI
00850014885007
510(k) Number
FDA Product Code
LLZ, IYO
GMDN Term
Ultrasound imaging system operation software
Device Class
Class II
Regulation Number
892.2050, 892.1560
GUDID distribution status
Not in Commercial Distribution

Other devices from Jointvue, LLC

  • 3D Echo

    Class II

  • jFit Surgical Planner

    Class II

  • 3D Echo v1.1

    Class II

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No