Home / 510(k) Clearances / K250597

510(k) K250597

REMEX Xcam6 by Remedi, Inc. — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2025
Date Received
February 28, 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 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)
  • 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)