Atlas FDA

BIOGRAPH TRUE PET/CT FAMILY SOFTWARE

FDA 510(k) clearance K141971 · decided 2014-09-12

Clearance details

K-number
K141971
Device name
BIOGRAPH TRUE PET/CT FAMILY SOFTWARE
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2014-07-21
Decision date
2014-09-12
Days to decision
53 days
Clearance type
Special
Product code
KPS
Device class
2
Regulation number
892.1200
Medical specialty
Radiology
Advisory committee
Radiology
Location
Knoxville, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Biograph 6 TruePoint, Material Number 10097289 The Biograph Mobile PET/CTs are intended to recall (Z-1422-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to recall (Z-1423-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 16 TruePoint - 3R, Material Number 10249555 The Biograph Mobile PET/CTs are inten recall (Z-1424-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph 16 TruePoint TrueV - 4R, Material Number 10249556 The Biograph Mobile PET/CTs are recall (Z-1425-2017)Siemens Medical Solutions USA Inc.2017-02-28
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are com recall (Z-2005-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems recall (Z-2006-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are recall (Z-2007-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are recall (Z-2008-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint sys recall (Z-2009-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint s recall (Z-2010-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint sy recall (Z-2011-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are recall (Z-2012-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are recall (Z-2013-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems recall (Z-2014-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint recall (Z-2015-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint s recall (Z-2016-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoi recall (Z-2017-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint syste recall (Z-2018-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint syste recall (Z-2019-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems a recall (Z-2020-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems a recall (Z-2021-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems a recall (Z-2022-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems a recall (Z-2023-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems a recall (Z-2024-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems a recall (Z-2025-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems recall (Z-2026-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems recall (Z-2027-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems a recall (Z-2028-2016)Siemens Medical Solutions USA Inc.2016-06-21
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are recall (Z-2029-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are recall (Z-2030-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are recall (Z-2031-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are recall (Z-2032-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are recall (Z-2033-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are com recall (Z-2034-2016)Siemens Medical Solutions USA Inc.2016-06-21
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TrueP recall (Z-2035-2016)Siemens Medical Solutions USA Inc.2016-06-21
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint recall (Z-2036-2016)Siemens Medical Solutions USA Inc.2016-06-21
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are recall (Z-2037-2016)Siemens Medical Solutions USA Inc.2016-06-21

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