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Sonocubic 3D Ultrasound Software Classic

by Medge Platforms, Inc. 2 variants

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 NumberB118314160 UDI-DI Date3 May 2016ListedStatusListed 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  • Withdrawn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
Sonocubic 3D Ultrasound Software
Generic Name
Ultrasound imaging system application software
Model / Reference
Classic
Primary DI / UDI-DI
B118314160
510(k) Number
FDA Product Code
IYO
GMDN Term
Ultrasound imaging system application software
Device Class
Class II
Regulation Number
892.1560
GUDID distribution status
Not in Commercial Distribution

Other devices from Medge Platforms, Inc.

Properties

  • Manufacturing Date

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: 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