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510(k) K253185

Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System by Carestream Health — Product Code IZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 11, 2026
Date Received
September 26, 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 Carestream Health

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • K251168 — Image Suite (September 4, 2025)
  • K241505 — DRX-Revolution Mobile X-ray System (December 10, 2024)
  • K233381 — DRX-Evolution Plus System (March 12, 2024)
  • K223842 — DRX - Compass (January 20, 2023)
  • K213568 — DRX-Rise Mobile X-ray System (March 23, 2022)
  • K213307 — Eclipse II with Smart Noise Cancellation (January 14, 2022)
  • K202441 — Eclipse II with Smart Noise Cancellation (April 2, 2021)
  • K203159 — Lux 35 Detector (December 2, 2020)
  • K201373 — DRX-Compass (June 26, 2020)

Other clearances for product code IZL

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