Home / 510(k) Clearances / K143257

510(k) K143257

KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System by Medicatech USA — Product Code KPR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2015
Date Received
November 13, 2014
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 Medicatech USA

  • K242731 — MasteRad MiniX Mobile Digital Imaging System (Mini-X) (May 16, 2025)
  • K230918 — MasterX 800 Series (September 1, 2023)
  • K190601 — MasteRad MX30 (April 25, 2019)
  • K130377 — KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (May 17, 2013)
  • K112132 — KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM (November 18, 2011)
  • K102284 — KRYSTALRAD 560 (FLAATZ 560) (January 3, 2011)
  • K102285 — KRYSTALRAD (ATAL8) (January 3, 2011)
  • K082798 — DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 (October 28, 2008)
  • K080582 — MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA (May 15, 2008)

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)