Home / 510(k) Clearances / K223550

510(k) K223550

DMX by Del Medical, Inc. — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2023
Date Received
November 25, 2022
Clearance Type
Abbreviated
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 Del Medical, Inc.

  • K173018 — MDR17 Mobile Direct Radiographic System (November 20, 2017)
  • K152767 — OTC12D AUTO RADIOGRAPHIC SYSTEM (December 14, 2015)
  • K140825 — DELWORKS DR SYSTEM (July 17, 2014)

Other clearances for product code KPR

  • K250954 — DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 dete (January 20, 2026)
  • 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)