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i12L-RS

by GE Parallel Design, Inc.

i12L-RS is a Class II device made by GE Parallel Design, Inc., cleared under FDA 510(k) K121063 on 21 Aug 2012 and listed in FDA GUDID since 15 Jul 2016 (UDI-DI 00840682107174), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. 2 FDA recalls are 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

2 ongoing

This device is named in the recall

Documents

510(k) K121063

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 Number00840682107174 UDI-DI Date15 Jul 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121063 Date21 Aug 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121063 decided 21 Aug 2012 Active
  • FDA GUDID UDI-DI 00840682107174 listed 15 Jul 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0752-2023 FDA Class II initiated 10 Nov 2022
    • Ongoing Z-0753-2023 FDA Class II initiated 10 Nov 2022

    Potential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch fire.

Timeline

4 dated events

  1. Cleared FDA 510(k) K121063
  2. Listed FDA GUDID 00840682107174
  3. Recall initiated FDA recalls Z-0752-2023
  4. Recall initiated FDA recalls Z-0753-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Surgical ultrasound imaging transducer
Model / reference
i12L-RS
Primary DI / UDI-DI
00840682107174
510(k) Number
FDA product code
IYO, LLZ, ITX, IYN
GMDN term
Surgical ultrasound imaging transducer
Device class
Class II
Regulation number
892.1560, 892.2050, 892.1570, 892.1550
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K121063)

Similar devices

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

Other devices from GE Parallel Design, Inc.

  • 4C

    Class II

  • 8l-Rs Open recall

    Class II

  • 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)