Atlas FDA

DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION

FDA 510(k) clearance K033244 · decided 2003-10-16

Clearance details

K-number
K033244
Device name
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
Applicant
Ge Medical Systems, Inc.
Decision
Substantially Equivalent
Date received
2003-10-07
Decision date
2003-10-16
Days to decision
9 days
Clearance type
Traditional
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innov recall (Z-1163-2014)GE Healthcare, LLC2014-03-10
GE Healthcare, Innova 3100 and Innova 4100 systems. The Digital Fluoroscopic Imaging Syste recall (Z-1616-2013)GE Healthcare, LLC2013-06-28
GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascular and Interventio recall (Z-1142-2013)GE Healthcare, LLC2013-04-18
GE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and recall (Z-0947-2013)GE Healthcare, LLC2013-03-13
Innova 2100IQ system with InnovaIQ Table Option Indicated for use in generating fluoroscop recall (Z-1921-2010)Ge Healthcare, Llc2010-06-29
Innova 3100/ 3100IQ system with InnovaIQ Table Option Indicated for use in generating fluo recall (Z-1922-2010)Ge Healthcare, Llc2010-06-29
Innova 4100/4100IQ system with InnovaIQ Table Option Indicated for use in generating fluor recall (Z-1923-2010)Ge Healthcare, Llc2010-06-29
GE Healthcare, GE Innova 4100 / 4100 IQ. , ( The system consists of an a monoplane positio recall (Z-0137-2010)GE Medical Systems, LLC2009-11-09

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011)Ge Medical Systems, Inc.2012-10-10
FETAL ACOUSTIC STIMULATOR (P870025/S010)Ge Medical Systems, Inc.2011-10-12
FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009)Ge Medical Systems, Inc.2010-04-23
FETAL ACOUSTIC STIMULATOR (P870025/S008)Ge Medical Systems, Inc.2006-03-02
COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007)Ge Medical Systems, Inc.2005-03-24
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006)Ge Medical Systems, Inc.2001-11-09
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005)Ge Medical Systems, Inc.1996-07-17
COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004)Ge Medical Systems, Inc.1996-02-01