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ThinkSono Guidance v2.3.0

by ThinkSono GmbH

Listed FDA GUDID listing, no authorization on record

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 NumberG080AUTODVT20 UDI-DI Date12 Aug 2026ListedStatusListed GUDID: 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  • Withdrawn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
ThinkSono Guidance
Generic Name
Ultrasound imaging system application software
Model / Reference
v2.3.0
Primary DI / UDI-DI
G080AUTODVT20
510(k) Number
FDA Product Code
QJU
GMDN Term
Ultrasound imaging system application software
Device Class
Class II
Regulation Number
892.2100
GUDID distribution status
In Commercial Distribution

Other devices from ThinkSono GmbH

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Serial Number: No
  • Expiration Date: No