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M4S

by GE Parallel Design, Inc.

M4S is a Class II device made by GE Parallel Design, Inc., cleared under FDA 510(k) K060542 on 31 Mar 2006 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682113045), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K060542

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682113045 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK060542 Date31 Mar 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K060542 decided 31 Mar 2006 Active
  • FDA GUDID UDI-DI 00840682113045 listed 15 Jul 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2989-2018 FDA Class II initiated 22 Mar 2018

    The system side of the power cord may break and expose the electrical conductors leading to the risk of shock.

Timeline

3 dated events

  1. Cleared FDA 510(k) K060542
  2. Listed FDA GUDID 00840682113045
  3. Recall initiated FDA recalls Z-2989-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Model / reference
M4S
Primary DI / UDI-DI
00840682113045
510(k) Number
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

Related devices

Cleared under the same submission (K060542)

Similar devices

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

Other devices from GE Parallel Design, Inc.

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    Class II

  • 8l-Rs Open recall

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  • 7S-Rs Open recall

    Class II

  • 4C-Rs Open recall

    Class II

See all devices from GE Parallel Design, Inc. →

Properties

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