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5S

by GE Parallel Design, Inc.

5S is a Class II device made by GE Parallel Design, Inc., listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682113311), not in commercial distribution (GUDID) as of 23 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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 Number00840682113311 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: not 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  • Withdrawn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
5S
Primary DI / UDI-DI
00840682113311
FDA product code
IYO, IYN, ITX
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class II
Regulation number
892.1560, 892.1550, 892.1570
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code IYO (System, imaging, pulsed echo, 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)