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510(k) K250954

DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector by Carestream Health — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2026
Date Received
March 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Stationary
Device Class
Class II
Regulation Number
892.1680
Review Panel
RA
Submission Type

Other clearances by Carestream Health

  • K253185 — Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System (March 11, 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 KPR

  • K252000 — uDR Arria & uDR Aris (November 26, 2025)
  • K251167 — uDR Aurora CX (September 19, 2025)
  • K250788 — Definium Tempo Select (August 28, 2025)
  • K250790 — INNOVISION-DXII (August 1, 2025)
  • K250738 — YSIO X.pree (July 31, 2025)
  • K242019 — GXR-Series Diagnostic X-Ray System (January 7, 2025)
  • K242499 — Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) (January 6, 2025)
  • K242119 — INNOVISION-EXII (January 3, 2025)
  • K241068 — uDR 780i (November 1, 2024)
  • K242847 — EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (October 23, 2024)