KPR · Class II · 21 CFR 892.1680

FDA Product Code KPR: System, X-ray, Stationary

FDA product code KPR covers stationary X-ray systems for fixed-installation diagnostic radiography.

These systems consist of a fixed X-ray tube, generator, and digital or analog image receptor used in radiology departments for routine chest, skeletal, and abdominal imaging. Modern stationary systems increasingly use flat panel digital detectors for immediate image capture and display.

KPR devices are Class II medical devices, regulated under 21 CFR 892.1680 and reviewed by the FDA Radiology panel.

Leading manufacturers include Samsung Electronics Co., Ltd., Siemens Medical Solutions USA, Inc. and Imaging Dynamics Company , Ltd..

357
Total
357
Cleared
94d
Avg days
1976
Since
357 devices
145–168 of 357
Cleared Jun 08, 2012
AERODR STITCHING SYSTEM
K120752
Konica Minolta Medical & Graphic, Inc.
Radiology · 88d
Cleared Jun 01, 2012
SR SUITE 1.0
K121345
Halifax Biomedical, Inc.
Radiology · 28d
Cleared May 23, 2012
AERODR X70
K121109
Konica Minolta Medical & Graphic, Inc.
Radiology · 41d
Cleared Apr 17, 2012
RADIOGRAPHIC X-RAY SYSTEM
K120034
Orich Medical Equipment (Tianjin Co., Ltd.
Radiology · 104d
Cleared Jan 25, 2012
PANORAD, PANORAD SL
K113855
Imix Adr Finland OY
Radiology · 27d
Cleared Jan 17, 2012
AERODR SYSTEM WITH P-21
K113248
Konica Minolta Medical & Graphic, Inc.
Radiology · 75d
Cleared Nov 30, 2011
FLAATZ 760
K111655
Drtech Corp.
Radiology · 170d
Cleared Oct 27, 2011
DX-D 600
K112670
Agfa Healthcare N.V.
Radiology · 43d
Cleared Aug 23, 2011
DDRELEMENT
K110828
Swissray Medical AG
Radiology · 152d
Cleared Aug 12, 2011
BRIVO XR385
K103448
Ge Medical Systems, LLC
Radiology · 261d
Cleared Apr 26, 2011
PRESTODR 4143
K110849
Cmt Medical Technologies, Ltd.
Radiology · 29d
Cleared Nov 24, 2010
AERODR SYSTEM
K102349
Konica Minolta Medical & Graphic, Inc.
Radiology · 97d
Cleared Oct 29, 2010
FDR IMAGE STITCHING OPTION
K101686
Fujifilm Medical System U.S.A., Inc.
Radiology · 135d
Cleared Oct 29, 2010
DX-D 300
K103050
Agfa Healthcare N.V.
Radiology · 14d
Cleared Jul 21, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830
VATECH Co., Ltd.
Radiology · 310d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889
Carestream Health, Inc.
Radiology · 26d
Cleared Mar 11, 2009
SEDECAL, MILLENNIUM PLUS
K090279
Sedecal., Sa.
Radiology · 35d
Cleared Feb 27, 2009
SEDECAL X-PLUS LP PLUS DIGITAL DIAGNOSTIC X-RAY SYSTEMS
K090238
Sedecal., Sa.
Radiology · 25d
Cleared Feb 13, 2009
DRAD30003/RADREX-I
K083503
Toshiba America Medical Systems, In.C
Radiology · 79d
Cleared Aug 22, 2008
YSIO
K081722
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836
Carestream Health, Inc.
Radiology · 30d
Cleared Apr 16, 2008
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
K080553
Vieworks Co., Ltd.
Radiology · 48d
Cleared Feb 06, 2008
FUJIFILM UNITY SPEEDSUITE, MODEL CR-IR 371
K073650
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 42d
Cleared Jun 22, 2007
X3C 2200 DIGITAL RADIOGRAPHIC SYSTEM
K071401
Imaging Dynamics Company , Ltd.
Radiology · 32d