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510(k) K093640

DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA by Electron Jsco. — Product Code IXK

K093640 is an FDA 510(k) premarket notification submitted by Electron Jsco. for the device "DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA". The FDA issued a decision of Substantially Equivalent on April 29, 2011. The device falls under product code IXK (System, Imaging, X-Ray, Electrostatic), a Class II device regulated under 21 CFR 892.1630.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2011
Date Received
November 24, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, X-Ray, Electrostatic
Device Class
Class II
Regulation Number
892.1630
Review Panel
RA
Submission Type

Other clearances for product code IXK

  • K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEM (December 11, 2007)
  • K042779 — RADIOTHERAPY SOLUTION BASED ON CR (October 21, 2004)
  • K032654 — PORT CASSETTE (October 9, 2003)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO (February 16, 2000)
  • K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515 (December 23, 1994)
  • K934949 — DIGORA (February 10, 1994)
  • K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS (June 8, 1993)
  • K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGE (December 17, 1992)
  • K924459 — DIGISCAN 2 (December 17, 1992)

FDA data resources