Atlas FDA

ARTIS ZEE AND ZEEGO

FDA 510(k) clearance K073290 · decided 2008-02-11

Clearance details

K-number
K073290
Device name
ARTIS ZEE AND ZEEGO
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2007-11-21
Decision date
2008-02-11
Days to decision
82 days
Clearance type
Traditional
Product code
IZI
Device class
2
Regulation number
892.1600
Medical specialty
Radiology
Advisory committee
Radiology
Location
Malvern, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Artis zee, Angiographic x-ray system recall (Z-1824-2017)Siemens Medical Solutions USA, Inc2017-03-30
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q. recall (Z-1284-2016)Siemens Medical Solutions USA, Inc2016-03-31
system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Arti recall (Z-1299-2016)Siemens Medical Solutions USA, Inc2016-03-31
Artis systems with large display from Siemens Medical Solutions USA, Inc. Interventional F recall (Z-0481-2016)Siemens Medical Solutions USA, Inc2015-12-24
Siemens Artis zee systems; dedicated angiography systems developed for single and biplane recall (Z-2340-2015)Siemens Medical Solutions USA, Inc2015-08-05
Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: recall (Z-0854-2015)Siemens Medical Solutions USA, Inc2015-01-14
The Artis zee / zeego Angiography System is designed as a set of components that may be co recall (Z-0486-2015)Siemens Medical Solutions USA, Inc2014-12-01
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is recall (Z-0183-2015)Siemens Medical Solutions USA, Inc2014-11-07
AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee / zeego are dedic recall (Z-2587-2014)Siemens Medical Solutions USA, Inc2014-09-24
Artis zee and Artis zeego systems. x-ray, angiographic system recall (Z-2569-2014)Siemens Medical Solutions USA, Inc2014-09-22
Artis Zee Angiographic x-ray systems. recall (Z-1309-2014)Siemens Medical Solutions USA, Inc2014-03-31
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems recall (Z-1272-2014)Siemens Medical Solutions USA, Inc2014-03-22
Siemens Artis zee Ceiling Systems. Angiographic x-ray system. recall (Z-1080-2014)Siemens Medical Solutions USA, Inc2014-02-24
ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have P recall (Z-1782-2013)Siemens Medical Solutions USA, Inc2013-07-22
Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. Ang recall (Z-0997-2013)Siemens Medical Solutions USA, Inc2013-03-26
AXIOM Artis MP/Artis dMP and Artis zee Multipurpose. Angiographic x-ray system. recall (Z-2233-2010)Siemens Medical Solutions USA, Inc2010-08-16
Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems recall (Z-0485-2010)Siemens Medical Solutions USA, Inc2009-12-03
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1443-2009)Siemens Medical Solutions USA, Inc2009-06-16
Axiom Artis Zee. Angiographic X-ray System. recall (Z-0194-2009)Siemens Medical Solutions USA, Inc2008-11-04

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21