JAA · Class II · 21 CFR 892.1650

FDA Product Code JAA: System, X-ray, Fluoroscopic, Image-intensified

Leading manufacturers include Toshiba America Medical Systems, In.C, Siemens Medical Solutions USA, Inc. and Fischer Imaging Corp..

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
49–72 of 300
Cleared Jun 03, 2011
LUMINOS AGILE
K111292
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared May 27, 2011
KALARE DIAGNOSTIC X-RAY TABLE SYSTEM
K110785
Toshiba Medical Systems Coporation, Japan
Radiology · 67d
Cleared Mar 29, 2011
DUET DRF
K103038
Cmt Medical Technologies, Ltd.
Radiology · 166d
Cleared Jun 30, 2010
UROSKOP OMNIA
K101491
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Oct 10, 2008
INFX-8000H, INFINIX-I
K082830
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 23, 2008
INFX-8000C (INFINIX CC-I AND VC-I)
K081621
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jun 17, 2008
INFX-8000V, INFINIX-CFI AND INFINIX VFI
K081582
Toshiba America Medical Systems, In.C
Radiology · 12d
Cleared Jun 11, 2008
PRECISION 500D R&F X-RAY SYSTEM
K081091
Ge Healthcare
Radiology · 56d
Cleared Jun 04, 2008
DRF 4343
K080859
Villa Sistemi Medicali S.P.A.
Radiology · 69d
Cleared Apr 05, 2007
FLUOROPRO RF DIGITAL IMAGING SYSTEM
K070390
Virtual Imaging, Inc.
Radiology · 55d
Cleared Jun 07, 2006
PRECISION THUNIS 800+
K061028
Ge Medical Systems, LLC
Radiology · 55d
Cleared Nov 30, 2005
IMAGE STAR II
K052610
Lakeshore Technologies, Inc.
Radiology · 69d
Cleared Jul 07, 2005
AXIOM SIRESKOP SD
K051602
Siemens Medical Systems, Inc.
Radiology · 21d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136
Smith & Nephew, Inc.
Radiology · 58d
Cleared May 13, 2005
FLUOROSCAN INSIGHT MINI C-ARM FLUOROSCOPIC IMAGING SYSTEM
K051025
Hologic, Inc.
Radiology · 21d
Cleared Apr 27, 2005
CENTRION 500 C-ARM SYSTEM
K050866
Osteosys Co.,Ltd
Radiology · 22d
Cleared Apr 08, 2005
FLXIS
K050692
Philips Medical Systems North America Co.
Radiology · 22d
Cleared Oct 22, 2004
UNFORS PATIENT SKIN DOSIMETER (PSD)
K042698
Unfors, Inc.
Radiology · 22d
Cleared May 17, 2004
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K040870
Shimadzu Corp.
Radiology · 45d
Cleared Mar 20, 2003
OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM
K024012
Ge Oec Medical Systems
Radiology · 106d
Cleared Dec 02, 2002
MODEL AMI1200 C-ARM
K022911
Integrity Practice Management, Inc.
Radiology · 90d
Cleared Nov 22, 2002
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
K022899
Philips Medical Systems North America Co.
Radiology · 80d
Cleared Oct 08, 2002
TELSTAR BIPLANE DIGITAL IMAGING SYSTEM [TIS] MODEL 030-000915
K022565
Stereotaxis, Inc.
Radiology · 67d