IXKClass II
System, Imaging, X-ray, Electrostatic
Radiology · 21 CFR 892.1630
MDR events4All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances14All time
Recent MDR events
4 adverse event reports on file
- FUJI COMPUTED RADIOGRAPHY FCR 9000 SYSTEMMar 25, 1998MalfunctionFuji Photo Film Co., Ltd.2443168-1998-00001
- SHIMADZU HS-10ASep 30, 1994MalfunctionShimadzu Medical Systems38771-1994-09001
- FUJIRADIOGRAPH DUPLICATORSep 23, 1994Techno-aide2443168-1994-00001
- FISCHER IMAGINGMar 8, 1993MalfunctionFischer Imaging3090
Event type breakdown
Malfunction3
Unspecified1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
14 clearances for this product code
- Electron Jsco.Apr 29, 2011
K093640 · DIGITAL X-RAY DETECTORS FAMILY KRC AND DIRA
- Portavision MedicalDec 11, 2007
K072766 · PVMED DDR 2520 DIGITAL IMAGING SYSTEM
- Agfa Corp.Oct 21, 2004
K042779 · RADIOTHERAPY SOLUTION BASED ON CR
- Orex Computed Radiography, Ltd.Oct 9, 2003
K032654 · PORT CASSETTE
- Canon USA, Inc.Jan 2, 2002
K003689 · CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
- Agfa Corp.Feb 16, 2000
K000159 · AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO
- Fujifilm Medical System U.S.A., Inc.Dec 23, 1994
K942561 · FUJI FCR IMAGE PROCESSING UNIT IP-U515
- Orion Corporation SoredexFeb 10, 1994
K934949 · DIGORA