FDA.reportPublic FDA data

Martin Pedroza

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96814753006303679Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30125637543012563754Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30129385643012938564Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30141280393014128039Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30157636553015763655Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30157773063015777306Martin Pedroza1N2026-01-01100 Park Avenue Suite 300 Orange Village OH US 44122
30335272733033527273Martin Pedroza1N2026-01-019965 Federal Drive Colorado Springs CO US 80921
30382818513038281851Martin Pedroza1N2026-01-019965 Federal Drive, Colorado Springs CO US 80921
30075620603007562060Martin Pedroza1N2020-04-25100 Park Avenue Suite 300 Orange Village OH US 44122

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2232271930027296P080003SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMOTE2011-02-11
2232271147200498K992506MINI 6800 DIGITAL MOBILE C-ARMOXO1999-08-19
2232271876148009K971684MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)LNH1997-08-05
2232271674272193K954451EVIS 140 SYSTEMFET1996-03-29
2324331596137549K253649Spectral CT Verida FamilyJAK2026-03-27
3049131596137549K253649Spectral CT Verida FamilyJAK2026-03-27
3049131421649109K252992CT Rembra RT; CT Areta RT; CT RembraJAK2026-03-23
2322101607660027K251484CT:VQJAK2025-08-28
2324331368217756K250648Philips iCT CT systemJAK2025-06-27
2322101305375653K250181AV ViewerLLZ2025-07-15
3331591305375653K250181AV ViewerLLZ2025-07-15
2324331224467713K244008Spectral CTJAK2025-05-16
3049131224467713K244008Spectral CTJAK2025-05-16
2138121701003842K243871Philips IntelliSite Pathology Solution 5.1PSY2025-03-06
2138121025615125K242848Philips IntelliSite Pathology Solution 5.1PSY2024-12-10
3331591276765900K242512ROCC ConsoleLLZ2024-10-24
2138121112555305K241871Philips IntelliSite Pathology SolutionPSY2024-12-02
2322101764703150K241847Imbio PHA (4.0.0)QIH2024-08-30
2324332018685888K240844Spectral CT 7500 RTJAK2024-10-18
3049132018685888K240844Spectral CT 7500 RTJAK2024-10-18
2672161847183863K240822Image Management V15LLZ2024-04-24
3331591847183863K240822Image Management V15LLZ2024-04-24
2138121679561529K233204Philips IntelliSite Pathology Solution 5.1PSY2024-06-24
3049131048670297K232491CT 5300JAK2024-05-03
2322101271715144K232392CT Lung Ventilation Analysis Software (CT:V)JAK2023-11-16
2322101214479075K232007CAAS MR SolutionsLLZ2024-02-01
2322101755418230K230112CAC SoftwareJAK2023-06-13
2322101573944088K220779XDLLZ2022-04-15
2324331126087719K212875Spectral CT on RailsJAK2022-05-13
3049131126087719K212875Spectral CT on RailsJAK2022-05-13
3049131011240304K212441Philips Incisive CTJAK2022-04-27
2322101542492401K211788HALOQAS2021-07-08
2324331994894882K211764Vereos PET/CTKPS2021-08-06
2324331792462691K210880Vereos PET/CTKPS2021-05-19
2324331781529071K193454IQon Spectral CTJAK2020-01-24
2322101621654737K193293XV Lung Ventilation Analysis SoftwareJAK2020-05-14
2138121748603061K192259Philips IntelliSite Pathology SolutionPSY2019-09-20
2232271901490780K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNH2019-06-04
2232271537703301K190138MAGNETOM AeraLNH2019-02-15
3331591434297284K182926IntelliSpace RadiologyLLZ2018-12-06
2232271987703575K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound SystemIYN2018-11-09
2232272008659078K181985Voluson E6, Voluson E8, Voluson E10IYN2018-11-15
2232271149420028K181727Vivid iqIYN2018-12-06
2232271578473081K180374Voluson S8/ Voluson S10/ Voluson S10 ExpertIYN2018-03-13
2322101309513932K173588Illumeo SystemLLZ2018-01-12
2322101314221101K172609CSMC Cardiac SuiteKPS2017-11-03
2232271116861370K172342Voluson E6, Voluson E8, Voluson E10IYN2017-09-29
2138121140154830K172174Philips IntelliSite Pathology SolutionPSY2017-10-04
2324331091718673K171850Philips CT Big BoreJAK2017-11-09
3049131091718673K171850Philips CT Big BoreJAK2017-11-09
2322101804522647K170981NeuroQuantLLZ2017-09-07
2672161476094589K170580Carestream Vue PACSLLZ2017-04-11
3331591476094589K170580Carestream Vue PACSLLZ2017-04-11
2324331978554078K163711IQon Spectral CTJAK2017-04-05
2324332033651223K162838Philips iCT CT SystemJAK2017-04-07
2322101934515524K162025IntelliSpace Portal PlatformLLZ2016-10-18
3331591934515524K162025IntelliSpace Portal PlatformLLZ2016-10-18
2322101482135504K161201ClearRead CTOEB2016-09-09
2324331602060175K160743Philips Ingenuity CTJAK2016-08-08
2322101019808633K1537363mensio WorkstationLLZ2016-05-27
2672162031112681K153103CARESTREAM Vue PACSLLZ2016-02-12
3331592031112681K153103CARESTREAM Vue PACSLLZ2016-02-12
2672161150384900K151774CARESTREAM Vue MotionLLZ2015-09-21
3331591150384900K151774CARESTREAM Vue MotionLLZ2015-09-21
2232271762331703K151451Aplio 500/400/300 Diagnostic Ultrasound System V6.0IYN2015-07-09
2232271831919538K151028LOGIQ eIYN2015-06-18
2232271366060907K143416SOMATOM Definition Flash (VA48)JAK2015-04-16
2232271883123059K143400SOMATOM Definition AS/AS+JAK2015-04-08
2232271247368999K143264H60 V2.00 Diagnostic Ultrasound SystemIYN2014-12-09
2232271222887573K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope PowerJAK2015-11-24
2232271765598216K142383Optima XR200amx, Optima XR220amxIZL2014-09-25
2232271964853282K141639VOLUSON S6, VOLUSON S8IYN2014-07-18
2322101615982805K141069Lung Density AnalysisJAK2014-09-17
2232271316322255K132934MULTIX SELECT DRKPR2014-04-10
2232271503534897K132913VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10IYN2013-11-08
2672161448272056K132824CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATIONLLZ2014-02-06
3331591448272056K132824CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATIONLLZ2014-02-06
2232271135215121K132027OEC 9800 PLUSOWB2014-05-01
2232271470495854K131634SYMBIAKPS2013-08-16
2232271676131313K131576OPTIMA CT660JAK2013-08-30
2322101357248702K130451NEUROQ 3.6KPS2013-05-17
2138121631797510K130021PHILIPS HERCEPTEST DIGITAL SCOREOEO2013-09-19
2232271730546157K123873CONTRAST ENHANCED DIGITAL MAMMOGRAPHYMUE2013-01-29
2322101426445412K123646EMORY CARDIAC TOOLBOX 4.0KPS2013-02-22
2324331556382693K123599INGENUITY DIGITAL PET/CTKPS2013-07-12
2232271476671081K123522OPTIMA MR450WLNH2013-03-13
2672162069136016K122523CARESTREAM VUE PACSLLZ2012-10-23
3331592069136016K122523CARESTREAM VUE PACSLLZ2012-10-23
2232271675542442K122234OEC 9900 ELITEOWB2012-08-16
2232271697054247K121959EVIS EXERA III VIDEO SYSTEMEOQ2013-01-10
2232271260787556K121062VIVID I DIAGNOSTIC ULTRASOUND SYSTEM, VIVID Q DIAGNOSTIC ULTRASOUND SYSTEMITX2012-08-17
2232271492314977K120833DISCOVERY CT750 HDJAK2012-06-12
2232271112999562K112391FUJINON COLONOSCOPESFDF2012-07-26
2232271221214336K111912MOBILETT MIRAIZL2011-09-19
2322101814093713K111336EBW NM 2.0LLZ2011-05-24
3331591814093713K111336EBW NM 2.0LLZ2011-05-24
2672161013067765K110919CARESTREAM PACSLLZ2011-10-20
3331591013067765K110919CARESTREAM PACSLLZ2011-10-20
2232271073195691K110798SENOGRAPHE DS, SENOGRAPHE ESSENTIALMUE2011-12-22
2232271041336500K110227OPTIMA CT660JAK2011-07-20
2232271615620773K103335GEM OPTION FOR 1.5 MRI SYSTEMSMOS2011-03-07
2232271729070980K103275SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMSMOS2011-01-11
2322101526179260K102687MIRADA RTLLZ2010-10-04
2232271750763450K102388VIVID I DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-11-04
2232271407648051K101768MIE SCINTRON GAMMA CAMERA SYSTEMSKPS2010-10-05
2183741210442860K101571XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMSMWI2010-10-26
2322101690769672K101279CORRIDOR4DM V2010 MODEL: V2010LLZ2010-08-04
2232271763471515K093849ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEMIYN2010-01-19
2232271806312348K0919021.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484MOS2009-08-21
2232271144911403K091658GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121OWB2009-06-29
2232271749304073K091536OPTIMA MR450WLNH2009-07-17
2322101685759147K091529ICAD VERALOOK CTC CAD SOFTWAREJAK2010-08-04
2232271125217677K082816GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEMJAK2008-10-08
2232271717329622K082761GE LIGHTSPEED 7.2 CT SCANNER SYSTEMJAK2008-10-08
2232271446056349K082427SYNGO MR B17LNH2008-11-07
2232271411045431K082185GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2IYO2008-08-15
2232272026714969K081722YSIOKPR2008-08-22
2232271104658080K081496OPTIMA PET/CT 560KPS2008-06-12
2232271431581779K081105GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)JAK2008-05-09
2232271017330608K081091PRECISION 500D R&F X-RAY SYSTEMJAA2008-06-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JAK392026-03-27
LLZ302025-07-15
IYN182018-12-06
LNH112019-06-04
KPS92021-08-06
OWB92014-05-01
PSY72025-03-06
MOS62011-03-07
KPR32014-04-10
OXO32005-06-01
IZL22014-09-25
MUE22013-01-29
EOQ22013-01-10
FDF22012-07-26
IYO22008-08-15
QIH12024-08-30
QAS12021-07-08
OEB12016-09-09
OEO12013-09-19
ITX12012-08-17
OTE12011-02-11
MWI12010-10-26
JAA12008-06-11
OLW12007-11-20
NWB12005-10-13
ODG12001-08-27
FET11996-03-29