Table, Radiographic, Stationary Top
Radiology · 21 CFR 892.1980
Recent MDR events
10 adverse event reports on file
- CONNEXION IMAGING MODULEApr 10, 2018MalfunctionMedical Intelligence Medizintechnik Gmbh9710332-2018-00001
- BK-200Mar 23, 2018MalfunctionShimadzu Coporation8030233-2018-00001
- SUMMIT INDUSTRIES LLCJun 8, 2016MalfunctionSummit Industries Llc.1450503-2016-00001
- SBRTFeb 13, 2015DeathMW5040803
- *Aug 19, 2014Carestream Health, Inc.4205656
- IBEAMAug 5, 2011OtherMedical Intelligence Medizintechnik-gmbh9710332-2011-00001
- UNIVERSAL COUCHTOP RECTANGULAR EXTENSIONJun 11, 2010OtherMedtec, Inc.1932738-2010-00002
- DEL EV200 TABLEJun 29, 2003InjuryDel Medical GroupMW1028854
- DIAGNOST 76 PLUSSep 15, 1997MalfunctionPhilips Systeme Medezin1217116-1997-00030
- SERIES 8000 BUCKYJun 3, 1993InjuryLiebel Flarsheim2126677-1993-00006
Event type breakdown
Recalls
7 recall events for this product code
- Civco Medical Instruments IncTerminatedAug 15, 2011
CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Z-3019-2011 · View FDA record ↗ - Civco Medical Instruments IncTerminatedAug 15, 2011
CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Z-3020-2011 · View FDA record ↗ - Civco Medical Instruments IncTerminatedAug 15, 2011
CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.
Z-3021-2011 · View FDA record ↗ - Med Tec IncTerminatedNov 16, 2010
CIVCO Rectangular Extension, REF MTIL6600, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA
Under certain conditions, the extensions can become detached from the main body of the couch.
Z-0394-2011 · View FDA record ↗ - Med Tec IncTerminatedNov 16, 2010
CIVCO Type-S Extension, REF MTIL6605, Reusable non-sterile extension for use with Universal Couchtop. The firm name on the label is CIVCO, Orange City, IA.
Under certain conditions, the extensions can become detached from the main body of the couch.
Z-0395-2011 · View FDA record ↗ - Med Tec IncTerminatedNov 16, 2010
CIVCO Posifix Extension, REF MTIL6606, Reusable non-sterile extension for use with the Universal Couchtop. The firm name on the label is CIVCO, Orange City, I
Under certain conditions, the extensions can become detached from the main body of the couch.
Z-0396-2011 · View FDA record ↗ - Med Tec IncTerminatedAug 20, 2009
Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
The silkscreened indexing scale was reversed.
Z-1721-2009 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
Philips Medical Systems Dmc Gmbh
HAMBURG, DE
Medtec Llc
Orange City, IA, US
Maquet Gmbh
RASTATT Baden-Wurttemberg, DE
Anholt Technologies Inc.
Avondale, PA, US
Brainlab Se
Munich Bavaria, DE
Accogent Pausch
Tinton Falls, NJ, US
3c-medical Intelligence Gmbh
Landsberg am Lech Bavaria, DE
Oakworks, Inc.
NEW FREEDOM, PA, US
Visaris D.o.o.
Zemun Beograd, RS
Core Labs, Llc.
ENGLEWOOD, CO, US
Shimane Shimadzu Corporation
IZUMO Shimane, JP
Radiation Products Design, Inc.
ALBERTVILLE, MN, US
Elekta Solutions Ab
STOCKHOLM, SE
Getinge Ab
POZNAN Wielkopolskie, PL
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Shimadzu Corporation Medical Systems Division
KYOTO, JP
Sedecal S.a.
ALGETE Madrid (Province), ES
Diacor, Inc.
Mount Pleasant, UT, US
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Summit Industries, Llc
Niles, IL, US
Philips Electronics Ltd
Mississauga Ontario, CA
Octostop, Inc.
LAVAL Quebec, CA
510(k) clearances
27 clearances for this product code
- Medtec, Inc.Dec 5, 1997
K973842 · CARBON FIBER CONFORMAL COUCH TOP
- Wuestec Medical, Inc.Jul 24, 1996
K960083 · MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300
- Medtec, Inc.Nov 14, 1995
K954225 · MED-TEC HAND GRIP
- Scott Imaging Intl., Inc.Feb 15, 1995
K946262 · EURO, SCST, SCCFT ATLAS RADIOLOGIC TABLES
- Octostop, Inc.Sep 8, 1994
K942916 · OCTOPAQUE UNIVERSAL
- Image Diagnostics, Inc.Aug 17, 1994
K942190 · ID100 MOBILE FLUOROSCOPIC EXAMINING TABLE
- Dial-A-RadNov 24, 1992
K913425 · DIAL-A-RAD PORTA RAD TABLE
- R-Made, Inc.Oct 20, 1992
K923775 · R-MADE HEAD/ARM SUPPORT