JAA · Class II · 21 CFR 892.1650

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

Leading manufacturers include Siemens Medical Solutions USA, Inc., General Electric Co. and Philips Medical Systems Dmc GmbH.

300
Total
300
Cleared
89d
Avg days
1976
Since
300 devices
25–48 of 300
Cleared Mar 15, 2019
SonialVision G4
K190373
Shimadzu Corporation
Radiology · 24d
Cleared May 21, 2018
MECALL CLISIS SYSTEMS, Discovery RF180
K173395
General Medical Merate S.P.A
Radiology · 203d
Cleared Apr 12, 2018
Uroview FD II
K180651
Pausch Medical GmbH
Radiology · 30d
Cleared Apr 05, 2018
DR 800 with MUSICA Dynamic
K180589
Agfa Healthcare N.V.
Radiology · 30d
Cleared Jun 03, 2011
LUMINOS AGILE
K111292
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Jun 30, 2010
UROSKOP OMNIA
K101491
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Jun 19, 2008
SMITH & NEPHEW CDS SYSTEM
K081491
Smith & Nephew, Inc.
Radiology · 22d
Cleared Jul 01, 2005
SMITH & NEPHEW CDS SYSTEM
K051136
Smith & Nephew, Inc.
Radiology · 58d
Cleared Jun 06, 2002
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
K021021
Siemens Medical Solutions USA, Inc.
Radiology · 69d
Cleared Sep 22, 1998
CAREGRAPH
K982319
Siemens Medical Solutions USA, Inc.
Radiology · 82d
Cleared Jul 14, 1998
FLUOROSPOT COMPACT
K982028
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared Mar 11, 1996
SIREGRAPH CF
K960266
Siemens Medical Solutions USA, Inc.
Radiology · 53d
Cleared May 15, 1995
SIRESKOP SX
K951358
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Sep 23, 1994
PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD
K943805
General Electric Co.
Radiology · 50d
Cleared Sep 07, 1993
SIRESKOP CX
K932445
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Nov 19, 1991
FLUROSPOT H VERSION 2
K914525
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Jul 19, 1991
LASER BEAM LOCALIZER FOR SIREMOBIL 4
K912380
Siemens Medical Solutions USA, Inc.
Radiology · 51d
Cleared Jun 22, 1987
LP LATERAL FLUORO POSITIONER (B5077A)
K872061
General Electric Co.
Radiology · 25d
Cleared Jun 16, 1986
SCX SYSTEM
K862120
General Electric Co.
Radiology · 13d
Cleared Nov 21, 1983
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530
General Electric Co.
Radiology · 59d
Cleared Feb 24, 1982
LATERAL ANGULATING FLUORO SUSPENSION
K820184
General Electric Co.
Radiology · 33d
Cleared Nov 06, 1981
FLUORICON L300 IMAGE INTENSIFIER
K812775
General Electric Co.
Radiology · 32d
Cleared Oct 13, 1981
LATERAL ANGULATING FLUORO SUSPENSION SYS
K812561
General Electric Co.
Radiology · 35d
Cleared Jan 09, 1981
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K802953
General Electric Co.
Radiology · 50d