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3.5C

by GE Parallel Design, Inc.

3.5C is a Class II device made by GE Parallel Design, Inc., listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682115254), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682115254 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
3.5C
Primary DI / UDI-DI
00840682115254
FDA product code
IYN, IYO, ITX
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class II
Regulation number
892.1550, 892.1560, 892.1570
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IYN (System, imaging, pulsed doppler, ultrasonic).

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See all devices from GE Parallel Design, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)