Atlas FDA

ARTISTE MV SA

FDA 510(k) clearance K072485 · decided 2007-12-27

Clearance details

K-number
K072485
Device name
ARTISTE MV SA
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2007-09-04
Decision date
2007-12-27
Days to decision
114 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
San Diego, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, O recall (Z-1059-2015)Siemens Medical Solutions USA, Inc2015-02-05
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expre recall (Z-0980-2015)Siemens Medical Solutions USA, Inc2015-01-15
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Ca recall (Z-2174-2014)Siemens Medical Solutions USA, Inc2014-08-10
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syn recall (Z-2180-2014)Siemens Medical Solutions USA, Inc2014-08-10
Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for ther recall (Z-1652-2014)Siemens Medical Solutions USA, Inc2014-05-23
550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiati recall (Z-1645-2014)Siemens Medical Solutions USA, Inc2014-05-21
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat b recall (Z-0438-2014)Siemens Medical Solutions USA, Inc2013-12-03
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Ma recall (Z-1092-2012)Siemens Medical Solutions USA, Inc2012-02-23
ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemna recall (Z-3003-2011)Siemens Medical Solutions USA, Inc2011-08-11
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the recall (Z-1970-2011)Siemens Medical Solutions USA, Inc2011-04-13
Siemens brand ARTISTE System Digital Linear Accelerator with the syngo RT Therapist versio recall (Z-1523-2011)Siemens Medical Solutions USA, Inc2011-03-04
Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the recall (Z-1422-2011)Siemens Medical Solutions USA, Inc., Concord, CA2011-02-24
Linear Medical Accelerator ARTISTE MV systems, when equipped with a syngo RT Therapist, Th recall (Z-1064-2011)Siemens Medical Solutions USA, Inc2011-02-08
Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat recall (Z-0449-2011)Siemens Medical Solutions USA, Inc2010-11-24
Siemens ARTISTE syngo RT Therapist, Therapist Assist, Therapist Express Basic, and Therapi recall (Z-0121-2010)Siemens Medical Solutions USA, Inc2009-11-05
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number recall (Z-1888-2009)Siemens Medical Solutions USA, Inc2009-09-24
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manuf recall (Z-0949-2009)Siemens Medical Solutions USA, Inc2009-01-30
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 12 recall (Z-0927-2009)Siemens Medical Solutions USA, Inc2009-01-29
Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Ve recall (Z-0857-2009)Siemens Medical Solutions USA, Inc2009-01-14
Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE recall (Z-0116-2009)Siemens Medical Solutions USA, Inc2008-10-20

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