Atlas FDA

MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS

FDA 510(k) clearance K021021 · decided 2002-06-06

Clearance details

K-number
K021021
Device name
MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2002-03-29
Decision date
2002-06-06
Days to decision
69 days
Clearance type
Traditional
Product code
JAA
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Iselin, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392 AXIOM Arti recall (Z-1150-2018)Siemens Medical Solutions USA, Inc2018-03-20
Axiom Artis systems. C-arm angiographic x-ray system x-ray, angiographic system. recall (Z-2108-2013)Siemens Medical Solutions USA, Inc2013-08-28
AXIOM Artis Systems VB23A-VB23H with Perivision functionality, Model Numbers: 5904433,5904 recall (Z-0144-2011)Siemens Medical Solutions USA, Inc2010-10-26
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 systems with Motor Controller Unit. Siemens Medical Solutions USA, Inc. Malver recall (Z-1732-2010)Siemens Medical Solutions USA, Inc2010-05-28
Axiom Artis Systems Operating with VB22, VB23, VB30, and VB31. Model number 5917054, 70086 recall (Z-1312-2010)Siemens Medical Solutions USA, Inc2010-04-08
Axiom Artis Systems operating with A100 Generator recall (Z-1237-2010)Siemens Medical Solutions USA, Inc2010-04-05
Axiom Artis dMP, Model number 7555365 angiographic x-ray systems recall (Z-0484-2010)Siemens Medical Solutions USA, Inc2009-12-03
Mavig Portegra 2 which is an accessory to the Siemens angiographic, fluoroscopic and radio recall (Z-1440-2009)Siemens Medical Solutions USA, Inc2009-06-16
Axiom Artis dFC, Axiom Artis Modular Angiography X-Ray System, Model number 7412807. recall (Z-0120-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBC-M, Axiom Artis Modular Angiography X-Ray System, Model number 5917054. recall (Z-0121-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dTA, Axiom Artis Modular Angiography X-Ray System, Model number 7008605. recall (Z-0122-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078. recall (Z-0123-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBA, Axiom Artis Modular Angiography X-Ray System, Model number 7555357. recall (Z-0124-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dFC-M, Axiom Artis Modular Angiography X-Ray System, Model number 7727717. recall (Z-0125-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dFA, Axiom Artis Modular Angiography X-Ray System, Model number 7555373. recall (Z-0126-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dMP, Axiom Artis Modular Angiography X-Ray System, Model number 7555365. recall (Z-0127-2009)Siemens Medical Solutions USA, Inc2008-11-25
Axiom Artis dBC, Axiom Artis Modular Angiography X-Ray System, Model number 7728392. recall (Z-0128-2009)Siemens Medical Solutions USA, Inc2008-11-25

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