Product code IXK— Radiology

FDA has cleared 14 devices under product code IXK between 1976 and 2011, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20111 clearance
• 20071 clearance
• 20041 clearance
• 20031 clearance
• 20021 clearance
• 20001 clearance
• 19942 clearances
• 19931 clearance
• 19923 clearances
• 19851 clearance
• 19761 clearance

• Fujifilm Medical System U.S.A., Inc.4 clearances
• Agfa Corp.2 clearances
• Xerox Medical Systems1 clearance
• Xeroradiography1 clearance
• Siemens Medical Solutions USA, Inc.1 clearance
• Portavision Medical1 clearance
• Orion Corporation Soredex1 clearance
• Orex Computed Radiography, Ltd.1 clearance
• Electron Jsco.1 clearance
• Canon USA, Inc.1 clearance

• K093640 — DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRAElectron Jsco.·2011-04-29
• K072766 — PVMED DDR 2520 DIGITAL IMAGING SYSTEMPortavision Medical·2007-12-11
• K042779 — RADIOTHERAPY SOLUTION BASED ON CRAgfa Corp.·2004-10-21
• K032654 — PORT CASSETTEOrex Computed Radiography, Ltd.·2003-10-09
• K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31Canon USA, Inc.·2002-01-02
• K000159 — AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLOAgfa Corp.·2000-02-16
• K942561 — FUJI FCR IMAGE PROCESSING UNIT IP-U515Fujifilm Medical System U.S.A., Inc.·1994-12-23
• K934949 — DIGORAOrion Corporation Soredex·1994-02-10
• K931002 — FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONSFujifilm Medical System U.S.A., Inc.·1993-06-08
• K923990 — FUJI COMPUTED RADIOGRAPHY HI-C652B DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.·1992-12-17
• K924459 — DIGISCAN 2Siemens Medical Solutions USA, Inc.·1992-12-17
• K924012 — FUJI COMPUTED RADIOGRAPHY HI-C653 DMS CRT IMAGEFujifilm Medical System U.S.A., Inc.·1992-10-16
• K853459 — XERORADIOGRAPHY LIQUID TONER IMAGING SYSTEMXerox Medical Systems·1985-10-30
• K761022 — XERORADIOGRAPHY 125 SYSTEM - MODIFIEDXeroradiography·1976-11-24