Home / 510(k) Clearances / K243864

510(k) K243864

BONX805 by Bontech Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2025
Date Received
December 17, 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 Bontech Co., Ltd.

  • K200787 — BSD3543W (April 23, 2020)

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)
  • 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)
  • K244049 — Europa (Alternative: AiRTouch) portable X-ray system (May 28, 2025)