ClearanceBrief
510(k) K163296 ยท JAK System, X-Ray, Tomography, Computed

SOMATOM go.Up, SOMATOM go.Now

ApplicantSiemens Medical Solutions USA, Inc., Malvern PA, US
DecisionSubstantially Equivalent, Mar 21, 2017
ReceivedNov 22, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K163296

DateFirm and productCodeLinked 510(k)
Mar 7, 2022Siemens Medical Solutions USA, Inc
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All 11061630 & 11061638 SOMATOM go.Top 11061640 & 1106
Open, Classified		 JAKNone listed
Mar 3, 2021Siemens Medical Solutions USA, Inc
Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Mo
Terminated		 JAKNone listed
Apr 20, 2018Siemens Medical Solutions USA, Inc
SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need for necessary patient rescans.
Terminated		 JAKNone listed
Apr 20, 2018Siemens Medical Solutions USA, Inc
SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for necessary patient rescans.
Terminated		 JAKNone listed
Oct 2, 2017Siemens Medical Solutions USA, Inc
SOMATOM Go.Up computed tomography (CT) x-ray system table, Model Number: 11061628 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-ra
Terminated		 JAKNone listed
Oct 2, 2017Siemens Medical Solutions USA, Inc
SOMATOM Go.Now computed tomography (CT) x-ray system table, Model Number: 11061618 Product Usage: Intended to generate and process cross-sectional images of patients by computer reconstruction of x-r
Terminated		 JAKNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.