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
217–240 of 358
Cleared Jun 01, 2005
KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345
K051258
Eastman Kodak Company
Radiology · 16d
Cleared Apr 08, 2005
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704
General Electric Co.
Radiology · 21d
Cleared Mar 18, 2005
UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS
K033577
Medlink Imaging
Radiology · 491d
Cleared Feb 09, 2005
MULTIDIAGNOST ELEVA
K050151
Philips Medical Systems North America, Inc.
Radiology · 16d
Cleared Nov 19, 2004
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025
Analogic Corp.
Radiology · 16d
Cleared Nov 18, 2004
URS LP DIGITAL, MILLENNIUM, RADPRO
K042876
Sedecal., Sa.
Radiology · 31d
Cleared May 25, 2004
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
K040995
Analogic Corp.
Radiology · 39d
Cleared Nov 19, 2003
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345
Analogic Corp.
Radiology · 30d
Cleared Jun 17, 2003
PHILIPS EASYDIAGNOST ELEVA
K031535
Philips Medical Systems North America Co.
Radiology · 32d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Oct 22, 2002
HCMI X-RAY
K022667
Health Care Mfg., Inc.
Radiology · 71d
Cleared Oct 22, 2002
HCMI X-RAY HIGH REQUENCY CHIROPRACTIC RADIOGRAPHIC
K022737
Health Care Mfg., Inc.
Radiology · 64d
Cleared Feb 01, 2002
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826
Siemens Medical Systems, Inc.
Radiology · 74d
Cleared Nov 02, 2001
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM
K012546
Sedecal USA, Inc.
Radiology · 87d
Cleared Nov 02, 2001
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481
GE Medical Systems
Radiology · 14d
Cleared Sep 19, 2001
OLDELFT THORASCAN MODEL NUMBER 180T
K012165
Nucletron Corp.
Radiology · 70d
Cleared Aug 10, 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Jun 20, 2001
Q-RAD RADIOGRAPHIC SYSTEM
K011486
Quantum Medical Imaging, LLC
Radiology · 36d
Cleared May 30, 2001
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
K011111
Modular X-Ray Devices
Radiology · 49d
Cleared Jun 02, 2000
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
K001336
Analogic Corp.
Radiology · 36d
Cleared Jun 02, 2000
DR5000 DEDICATED CHEST X-RAY SYSTEM
K001341
Analogic Corp.
Radiology · 36d
Cleared Jun 01, 2000
MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS
K001201
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Dec 21, 1999
PENSIL TRAUMA, MODEL WWS6100
K993962
Wuestec Medical, Inc.
Radiology · 57d
Cleared Nov 12, 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665
Ge Medical Systems, Inc.
Radiology · 14d