FDA.reportPublic FDA data

Robert Phillips

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30047542113004754211Robert Phillips1N2026-01-0140 Liberty Boulevard MALVERN PA US 19355
30049773353004977335Robert Phillips1N2026-01-0140 Liberty Boulevard MALVERN PA US 19355

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
88761749934006P140011MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTIONOTE2015-04-21
88761772811212K992925AX WORKSTATION DR-VIEWER SOFTWARE OPTIONLLZ1999-11-23
88761310799481K992073AX WORKSTATIONLLZ1999-09-09
88761443208410K991922DIGITAL IMAGING SYSTEM (BSR)IZI1999-09-01
88761528058304K990426CALCIUM SCORINGJAK1999-05-12
88761653469149K9846343D-ANGIOJAK1999-03-12
88761214163541K982536PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGEJAK1998-11-24
88761548900779K982028FLUOROSPOT COMPACTJAA1998-07-14
88761829905282K971452MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLEIZZ1997-05-14
88761275874229K971054OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMSJAK1997-06-13
88761365871570K963093SIREMOBIL COMPACTOXO1996-09-03
88761854883343K960635PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMSJAK1996-04-03
88761430150397K951006KENEX MOBILE CASSETT HOLDER (AS EXHIBIT #7)IXA1995-04-03
88761296182249K945293TOP ACOM STATIONIZI1995-01-05
88761891379514K932672MAMMOMAT 300 AND MAMMOMAT 3000IZH1994-09-14
88831962914645K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH2026-02-23
88761354511525K254184syngo Application SoftwareQIH2026-04-29
88761727155931K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB2026-04-24
88761407732232K253752ARTIS genio floor; ARTIS icono.explore floorOWB2026-04-23
88761030827994K253574SOMATOM X.cite; SOMATOM X.ceedJAK2026-03-20
88761747129426K253495syngo.MR Applications (VB80)LLZ2025-11-20
88831359420539K253023BIOGRAPH OneOUO2026-01-15
88831475600509K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Vida Fit; MAGNETOM Flow.Elite; MAGNETOM Flow.Neo; MAGNETOM Flow.RiseLNH2025-12-19
88831077874341K251822MAGNETOM Free.Max; MAGNETOM Free.StarLNH2025-11-20
88761568097465K251805syngo.CT Dual EnergyJAK2025-10-15
88761143541106K251523Cios SpinOWB2025-07-29
88761506916624K251520Cios Alpha; Cios FlowOWB2025-07-09
88761182299978K251061NAEOTOM Alpha.Peak/NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK2025-07-28
88761339958495K251059Syngo Carbon Clinicals (VA41)QIH2025-10-24
88761408539112K250822SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.PulseJAK2025-07-03
88761556203295K250738YSIO X.preeKPR2025-07-31
88761064931734K250660LUMINOS Q.namix T; LUMINOS Q.namix ROWB2025-07-14
88831286544825K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileLNH2025-06-16
88831934556876K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusLNH2025-06-16
88761931041097K243523NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.PrimeJAK2025-02-12
88761247467457K243145syngo.CT LVO DetectionQAS2025-04-10
88761809434036K241757syngo.CT Dual EnergyJAK2025-01-03
88762000361693K241572ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)OWB2024-10-22
88761265402701K241569syngo Application SoftwareLLZ2024-10-11
88761853493065K241295SOMATOM On.siteJAK2024-09-03
88761737221007K240294Syngo Carbon Enterprise Access (VA40A)LLZ2024-05-23
88761678273213K233748CIARTIC Move (VB10)OWB2024-03-15
88761427413957K233657NAEOTOM AlphaJAK2024-03-28
88761170526621K233650SOMATOM go.Up; SOMATOM go.Now; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceedJAK2024-03-26
88761867739675K233543YSIO X.preeKPR2024-05-21
88761790457330K233539MAMMOMAT B.brilliantMUE2024-03-27
88761094638133K232856Syngo Carbon ClinicalsQIH2023-12-01
88761755647550K232799syngo.via RT Image SuiteMUJ2024-04-26
88831840508341K232765MAGNETOM Cima.X FitLNH2024-02-29
88762033622702K232744syngo Virtual Cockpit (VB10A)LLZ2023-12-21
88831341964351K232535MAGNETOM Sola; MAGNETOM AlteaLNH2023-12-22
88761569552220K232431syngo.CT Brain HemorrhageQAS2024-03-22
88761569253614K232206SOMATOM Pro.PulseJAK2023-12-06
88761985741414K232155syngo.CT Dual EnergyJAK2023-11-30
88761637481819K232136syngo.CT ApplicationsJAK2024-01-04
88832067457598K231617MAGNETOM Free.Max; MAGNETOM Free.StarLNH2023-11-09
88831438113068K231587MAGNETOM Cima.XLNH2023-12-18
88761226493349K231577MOBILETT ImpactIZL2023-07-25
88831302762395K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fitLNH2023-10-23
88761525488488K231157syngo.CT Lung CAD (Version VD30)OEB2023-07-19
88761373025785K230955syngo Application SoftwareLLZ2023-12-20
88761943129420K230950ARTIS icono (VE30A)OWB2023-12-14
88761095295246K230949ARTIS pheno (VE30A)OWB2023-12-15
88761629078972K230561Syngo Carbon Space VA30ALLZ2023-03-21
88761703333667K230421SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition FlashJAK2023-06-16
88761475951337K230196syngo.via View&GO VA40ALLZ2023-02-13
88761094072417K223812Sensis Vibe (VD15)DQK2023-09-15
88762063753210K223363MAMMOVISTA B.smart (VB70)LLZ2023-01-12
88831735283270K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitLNH2022-09-13
88761296293721K221727syngo.CT Extended FunctionalityJAK2022-07-13
88761333060397K221516ARTIS icono (Ceiling Configuration)OWB2022-07-19
88761940636166K221501syngo.via View&GOLLZ2022-10-14
88761035715773K221281Multitom RaxOWB2022-11-17
88761060315058K221219syngo.CT CaScoringJAK2022-05-17
88761710749199K220814NAEOTOM Alpha, Scan&GO SoftwareJAK2022-07-12
88761345928754K220783syngo.via RT Image SuiteMUJ2022-09-07
88831629575468K220575MAGNETOM Free.Max, MAGNETOM Free.StarLNH2022-06-24
88761918873962K220450syngo.CT ApplicationsJAK2022-03-07
88761623651520K220433syngo Application Software (VE21)LLZ2022-08-16
88762039778139K220432ARTIS icono (VE21) SystemOWB2022-06-29
88761536937719K220409ARTIS pheno (VE21) SystemOWB2022-06-29
88762058729735K214019syngo.CT Extended FunctionalityJAK2022-01-20
88831464846414K213693MAGNETOM Vida with syngo MR XA50ALNH2022-02-25
88761812118945K213665Syngo Carbon Space VA20ALLZ2022-06-21
88761373337571K213096Al-Rad Companion (Pulmonary)JAK2021-12-06
88761382878180K212889Syngo.CT Dual EnergyJAK2022-03-28
88761693382464K212851EchoSK and EchoSGyn modules for EchoS Family devicesIYO2022-03-16
88761390801760K212621MAMMOVISTA B.smartLLZ2021-11-12
88761686282720K212212Multitom Rax with True2scale Body Scan OptionOWB2022-02-18
88761560352879K211591NAEOTOM Alpha, Scan&GOJAK2021-09-30
88761951681768K211379syngo.via RT Image SuiteMUJ2021-07-30
88761993944999K211373SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO SoftwareJAK2021-08-27
88831416924230K210611MAGNETOM Free.MaxLNH2021-07-01
88761344526182K210055Cios AlphaOWB2021-02-05
88761966693746K210054Cios SpinOWB2021-02-05
88761376076180K203504Cios FlowOWB2020-12-22
88831766247299K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaLNH2021-03-31
88761650870151K203411syngo.CT Skull UnfoldingJAK2021-07-22
88762019637030K203260syngo.CT Brain HemorrhageQAS2022-01-28
88762068134243K203258syngo.CT Lung CADOEB2021-03-31
88761720910350K202514EchoS FamilyMUA2021-02-25
88761268195469K202213syngo.CT Neuro PerfusionJAK2020-10-11
88831798593259K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitLNH2020-09-08
88761377653478K201670YSIO X.preeKPR2020-10-21
88761066306848K201477syngo.via View&GOLLZ2020-07-01
88761032667323K201444Syngo.via RT Image SuiteMUJ2020-08-13
88761063129432K201156ARTIS pheno (VE2)OWB2020-06-29
88761420529771K201034Syngo.CT CaScoringJAK2020-05-14
88761513793426K200524SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GOJAK2020-04-01
88761850498794K200515syngo.CT Cardiac PlanningJAK2020-03-25
88761196952024K200015ePM Series Patient monitorsMHX2020-06-08
88761438145071K193326ARTIS IconoOWB2020-04-16
88761847715567K193267Al-Rad Companion (Musculoskeletal)JAK2020-03-16
88761402054954K193216syngo.CT Lung CADOEB2020-03-09
88761675395249K193166MAMMOMAT RevelationMUE2020-06-12
88761089506777K192763syngo.CT CaScoringJAK2019-12-17
88761837469099K192462syngo.MR ApplicationsLLZ2020-01-31
88761888133396K192402syngo.CT Extended FunctionalityJAK2019-09-20
88762015354506K192065Syngo.Via RT Image SuiteMUJ2019-09-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK1242026-03-20
LLZ582025-11-20
LNH462026-02-23
OWB402026-04-24
KPR92025-07-31
MUJ72024-04-26
MUE72024-03-27
OEB62023-07-19
IZI62009-06-18
JAA52011-06-03
DQK42023-09-15
IZL42023-07-25
MOS42011-08-25
OXO42005-06-01
QIH32026-04-29
QAS32025-04-10
LNS32012-06-12
LHN22017-04-05
NWE22014-12-03
IZH22001-02-02
OUO12026-01-15
IYO12022-03-16
MUA12021-02-25
MHX12020-06-08
DQA12017-12-15
OTE12015-04-21
LMC12007-10-25
IZZ11997-05-14
IXA11995-04-03