Instrument, Quality-assurance, Radiologic
Radiology · 21 CFR 892.1940
Recent MDR events
8 adverse event reports on file
- MICROSTAR DEVICEJan 5, 2023LandauerMW5114191
- IC PROFILER-MRSep 3, 2014MalfunctionSun Nuclear Corp.1038814-2014-00001
- QEDMay 1, 2012Sun Nuclear Corporation2564685
- NANODOTDec 14, 2011OtherLandauer Inc3008426232-2011-00001
- NANODOTSOct 12, 2011MalfunctionLandauer, IncMW5022660
- EXRADINMay 27, 2003MalfunctionStandard Imaging, Inc.2184007-2003-00001
- EXRADINMay 27, 2003MalfunctionStandard Imaging, Inc.2184007-2003-00002
- EXRADINMay 27, 2003MalfunctionStandard Imaging, Inc.2184007-2003-00003
Event type breakdown
Recalls
2 recall events for this product code
- LandauerCompletedMar 21, 2024
microStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201), 10016-000 (marketed in EMEA as 101), 10036-000, 10044-000, 10055-000,
Permanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot or any otherbdosimeter for medical applications from the product s user manual and software and to remove microStar readers from customers who use them only for medical applications.
Z-1349-2024 · View FDA record ↗ - Mevion Medical Systems, Inc.TerminatedUnknown
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
Z-2686-2020 · View FDA record ↗
Registered firms
63 firms currently registered for this product code
Carl Zeiss Meditec Ag (oberkochen)
OBERKOCHEN Baden-Wurttemberg, DE
De.tec.tor S.r.l.
Torino, IT
Standard Imaging, Inc.
MIDDLETON, WI, US
Ptw Freiburg
FREIBURG Baden-Wurttemberg, DE
Zimmer Cas
MONTREAL, QUEBEC, CA
Therapixel Inc.
Chicago, IL, US
Leo Cancer Care Incorporated
Middleton, WI, US
Vacutec Messtechnik Gmbh
DRESDEN Saxony, DE
Varian Medical Systems Imaging Laboratory Gmbh
Daettwil, Argovia Aargau, CH
Lap Gmbh Laser Applikationen
LUENEBURG Lower Saxony, DE
Quality Electrodynamics
Mayfield Village, OH, US
Accuray Incorporated
MADISON, WI, US
Agfa N.v.
Mortsel Antwerpen, BE
Qualiformed Sas
La Roche Sur Yon Pays de la Loire, FR
Philips Medical Systems Nederland B.v.
BEST Noord-Brabant, NL
Ashland Specialty Ingredients, G.p.
Bridgewater, NJ, US
Radiation Products Design, Inc.
ALBERTVILLE, MN, US
Konica Minolta Technoproducts Co., Ltd.
SAYAMA-SHI Saitama, JP
Ashland
Columbus, OH, US
Varian Medical Systems, Inc
PALO ALTO, CA, US
Therapixel
Nice Alpes-Maritimes, FR
Barco N.v.
KORTRIJK West-Vlaanderen, BE
Ge Hangwei Medical Systems Co., Ltd.
Beijing, CN
Anzai Medical Co, Ltd.
SHINAGAWA-KU Tokyo, JP
510(k) clearances
8 clearances for this product code
- Standard Imaging, Inc.Nov 15, 2004
K042733 · STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM
- Radiation Measurements, Inc.Oct 30, 1987
K873956 · ULTIMETER
- Victoreen, Inc.May 7, 1986
K860260 · MULTI PURPOSE MODEL 76-903
- Victoreen, Inc.May 7, 1986
K853754 · MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901
- Victoreen, Inc.Apr 22, 1986
K860100 · MRI SLICE THICKNESS & CONTIGUITY PHANTOM #76-902
- Varian Assoc., Inc.Jul 1, 1985
K844620 · BDS-3 BEAM DATA SCANNER
- Varian Assoc., Inc.Jul 1, 1985
K845007 · RFA-7 RADIATION FIELD ANALYZER
- Radiation Measurements, Inc.Mar 5, 1984
K834483 · DIGI-X