Home / 510(k) Clearances / K253058

510(k) K253058

Portable DR Imaging System by Shantou Institute of Ultrasonic Instruments Co., Ltd. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
September 22, 2025
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 Shantou Institute of Ultrasonic Instruments Co., Ltd.

  • K243178 — Digital Color Doppler Ultrasound Imaging System (Apogee C1); Digital Color Doppl (March 31, 2025)
  • K243132 — Digital Color Doppler Ultrasound Imaging System (Readius L15); Digital Color Dop (December 10, 2024)

Other clearances for product code IZL

  • K260085 — RAYMO Mobile X-ray System (Model: RAYMO) (May 14, 2026)
  • 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)