MAUDE MDR 9105397

MDR report key: 9105397
Report number: 3002466018-2019-96544
Event key: 0
Event type: 3
Date of event: 2019-09-02
Date received: 2019-09-23
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: REBECCA TUDOR
Address: 40 LIBERTY BLVD. 65-1A MALVERN PA 19355 US
Phone: 610-610-6104
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	SIMVIEW NT	SYSTEM, SIMULATION, RADIATION THERAPY	SIEMENS HEALTHCARE GMBH	KPQ	5497016						Y	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-09-23	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00856545006003	Acuity iX Radiation Therapy Simulation System	VARIAN MEDICAL SYSTEMS, INC.	KPQ	2020-09-20
07540180000238	Clarity®	Elekta Solutions AB	KPQ	2020-06-19
00856545006010	Varian Acuity with Conebeam Computed Tomography	VARIAN MEDICAL SYSTEMS, INC.	KPQ	2020-06-04
07540180000221	Clarity®	Elekta Solutions AB	KPQ	2020-05-22
07540180000214	Clarity®	Elekta Solutions AB	KPQ	2019-03-27
07540180000207	Clarity®	Elekta Ltd	KPQ	2018-11-19
00815212022012	IZ Ports	Izi Medical Products, LLC	KPQ	2017-02-08
00815212022050	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2017-02-07
00815212022067	ShadowForm marker	Izi Medical Products, LLC	KPQ	2017-02-07
00815212022074	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2017-02-07
00815212022111	IZ Ports	Izi Medical Products, LLC	KPQ	2017-02-02
00815212022128	IZ Ports	Izi Medical Products, LLC	KPQ	2017-02-02
00815212022135	IZ Ports	Izi Medical Products, LLC	KPQ	2017-02-02
00815212022142	IZ Ports	Izi Medical Products, LLC	KPQ	2017-02-02
07540180000184	Clarity®	Elekta Ltd	KPQ	2017-01-10
00815212021695	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
00815212021701	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
00815212021718	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
00815212021725	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
00815212021732	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
00815212021749	ShadowForm Marker	Izi Medical Products, LLC	KPQ	2016-11-17
07540180000016	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000023	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000030	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000047	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000054	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000061	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000078	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000085	Clarity®	Elekta Solutions AB	KPQ	2016-09-23
07540180000092	Clarity®	Elekta Solutions AB	KPQ	2016-09-23

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K132944	KPQ	ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION	Ge Hungary Kft	2014-03-14
510(k)	K132045	KPQ	ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONS	Ge Hungary Kft	2013-09-04
510(k)	K101038	KPQ	RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER	Acceletronics Digital Imaging, LLC	2010-08-17
510(k)	K090706	KPQ	ONCENTRA SIMULATION 2.3	Nucletron Corporation	2009-06-15
510(k)	K083591	KPQ	IKOENGELO, VERSION 2	Ikoetech, LLC	2008-12-29

MAUDE MDR 9105397

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#