Home / 510(k) Clearances / K244049

510(k) K244049

Europa (Alternative: AiRTouch) portable X-ray system by Livermoretech, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2025
Date Received
December 31, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Mobile
Device Class
Class II
Regulation Number
892.1720
Review Panel
RA
Submission Type

Other clearances by Livermoretech, Inc.

  • K193535 — EZER, Portable X-ray System (May 7, 2020)
  • K200022 — FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System (April 3, 2020)
  • K193644 — E-COM DR-2000 DR (February 14, 2020)
  • K190935 — EZER, Portable X-ray System (December 19, 2019)
  • K180663 — LaVid FMTS DIAGNOSTIC X-RAY SYSTEM (May 18, 2018)

Other clearances for product code IZL

  • K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (March 11, 2026)
  • K253244 — AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) (February 23, 2026)
  • K250976 — Airbile-100 (December 19, 2025)
  • K251710 — Mobile X-ray unit (!M1) (October 24, 2025)
  • K243864 — BONX805 (September 12, 2025)
  • K251443 — PROMO (August 22, 2025)
  • K251223 — HnX-P1, HnX-PB (August 4, 2025)
  • K250597 — REMEX Xcam6 (July 31, 2025)
  • K243473 — PRORAD ATLAS ULTRAPORTABLE; PRORAD ATLAS ULTRAPORTABLE PLUS (July 29, 2025)
  • K250750 — INNOVISION-P5 (July 18, 2025)