Atlas FDA

AXIOM LUMINOS DRF

FDA 510(k) clearance K062623 · decided 2007-08-22

Clearance details

K-number
K062623
Device name
AXIOM LUMINOS DRF
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2006-09-05
Decision date
2007-08-22
Days to decision
351 days
Clearance type
Traditional
Product code
OWB
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mavern, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoro recall (Z-1164-2023)Siemens Medical Solutions USA, Inc2023-02-23
Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluorosco recall (Z-1166-2023)Siemens Medical Solutions USA, Inc2023-02-23
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and recall (Z-1668-2015)Siemens Medical Solutions USA, Inc2015-05-23
Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 and SmartOrtho recall (Z-0994-2015)Siemens Medical Solutions USA, Inc2015-01-16
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a un recall (Z-0003-2015)Siemens Medical Solutions USA, Inc2014-10-02
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is inten recall (Z-2649-2014)Siemens Medical Solutions USA, Inc2014-09-16
Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to b recall (Z-2292-2014)Siemens Medical Solutions USA, Inc2014-09-10
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software version recall (Z-1845-2014)Siemens Medical Solutions USA, Inc2014-06-21
AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a universal diagno recall (Z-1711-2014)Siemens Medical Solutions USA, Inc2014-06-04
Siemens RAD Fluoro Uro system (Luminos dRF and Uroskop Omnia with software version VD10A/G recall (Z-0140-2014)Siemens Medical Solutions USA, Inc2013-11-27
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia syste recall (Z-0374-2014)Siemens Medical Solutions USA, Inc2013-11-26
Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software version recall (Z-0016-2014)Siemens Medical Solutions USA, Inc2013-11-01
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system recall (Z-1848-2013)Siemens Medical Solutions USA, Inc2013-08-01
Siemens Axiom Luminos dRF solid state x-ray imager Solid state x-ray imager (flat panel/di recall (Z-1383-2012)Siemens Medical Solutions USA, Inc2012-04-09
Siemens Ysio, AXIOM Luminos dRF, AXIOM Luminos Agile/TF, Uroskop Omnia Solid state x-ray i recall (Z-1159-2012)Siemens Medical Solutions USA, Inc2012-03-05
AXIOM SIRESKOP SD, SIRESKOP SX, AXIOM LUMINOS System, X-Ray, Fluoroscopic, image-intensifi recall (Z-1421-2011)Siemens Medical Solutions USA, Inc2011-02-23
Axiom Luminos dRF Intended use: solid state x-ray imager (flat panel/digital imager) recall (Z-0717-2011)Siemens Medical Solutions USA, Inc2010-12-17
SIEMENS AXIOM Luminos TF and Sireskop SD Solid State x-ray imager (flat panel/digital imag recall (Z-2222-2010)Siemens Medical Solutions USA, Inc2010-08-13
Axiom Luminos dRF with ST filter. Solid state x-ray imager (flat panel/digital imager). Mo recall (Z-0326-2009)Siemens Medical Solutions USA, Inc2008-11-28
Axiom Luminos dRF without ST filter. . Solid state x-ray imager (flat panel/digital imager recall (Z-0327-2009)Siemens Medical Solutions USA, Inc2008-11-28

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