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..

358
Total
358
Cleared
94d
Avg days
1976
Since
358 devices
169–192 of 358
Cleared Jul 21, 2010
DIGITAL X-RAY IMAGING SYSTEM, MODEL DRC-1000
K092830
VATECH Co., Ltd.
Radiology · 310d
Cleared Nov 12, 2009
VIZTEK WL
K091752
Viztek, Inc.
Radiology · 149d
Cleared Aug 25, 2009
IMASIGHT 4600 DIGITAL RADIOGRAPHY SENSOR
K092307
Imasight, Inc.
Radiology · 26d
Cleared Jul 20, 2009
DRX-EVOLUTION, MODEL VX3733-SYS
K091889
Carestream Health, Inc.
Radiology · 26d
Cleared Jul 01, 2009
FLAATZ 500
K091747
Drtech Corp.
Radiology · 15d
Cleared Jun 29, 2009
DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D
K083640
Choong Wae Medical Corp.
Radiology · 202d
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 Jan 08, 2009
KUBTEC XPERT 20
K083510
Kub Technologies, Inc.
Radiology · 43d
Cleared Dec 04, 2008
SUINSA DIAGNOSTIC X-RAY SYSTEM
K083109
Suinsa
Radiology · 45d
Cleared Nov 26, 2008
QV-9000 UNIVERSAL SYSTEM
K083181
Quantum Medical Imaging, LLC
Radiology · 29d
Cleared Nov 21, 2008
VIZTEK DR, MODELS: DR1000, DR3000, DR4000
K082604
Viztek, Inc.
Radiology · 74d
Cleared Nov 06, 2008
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K082261
Dxrad Solutions , Ltd.
Radiology · 90d
Cleared Oct 28, 2008
DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000
K082798
Medicatech USA
Radiology · 35d
Cleared Aug 22, 2008
YSIO
K081722
Siemens Medical Solutions USA, Inc.
Radiology · 65d
Cleared Aug 22, 2008
RADVISION ET DIAGNOSTIC X-RAY SYSTEM
K082064
Almana Medical Imaging
Radiology · 32d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836
Carestream Health, Inc.
Radiology · 30d
Cleared Jun 20, 2008
DR VISION NEO, DR VISION DOU
K080614
Almana Medical Imaging
Radiology · 107d
Cleared May 15, 2008
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA
K080582
Medicatech USA
Radiology · 73d
Cleared May 09, 2008
CHRYSALIS
K080655
Meta Imaging Solutions, LLC
Radiology · 63d
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 Jan 17, 2008
IMIX INSIGHT X-RAY SYSTEMS
K073114
Imix Adr Finland OY
Radiology · 73d