Home / 510(k) Clearances / K130377

510(k) K130377

KRYSTALRAD NEW SERIESDIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM by Medicatech USA — Product Code MQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2013
Date Received
February 14, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
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)
  • K143257 — KrystalRad 11000 and KrystalRad 3000 Digital Stationary Radiographic System (February 6, 2015)
  • 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 MQB

  • K252911 — Lux HD 2530 detector (Lux HD 2530) (October 9, 2025)
  • K250211 — Yushan X-Ray Flat Panel Detector (July 22, 2025)
  • K250665 — SKR 3000 (June 17, 2025)
  • K243734 — Wireless/ Wired X-Ray Flat Panel Detectors (April 18, 2025)
  • K242770 — EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG (March 20, 2025)
  • K243443 — EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXP (March 19, 2025)
  • K243556 — Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) (March 18, 2025)
  • K244010 — ExamVue Apex (February 24, 2025)
  • K243171 — Yushan X-Ray Flat Panel Detector (December 19, 2024)
  • K241319 — SKR 3000 (November 21, 2024)