FDA.reportPublic FDA data

Maria Heiling

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30037682773002807880Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130
30095296303009529630Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130
30335259873033525987Maria Heiling1N2026-01-013721 Valley Centre Dr Ste 500 San Diego CA US 92130
30335277703033527770Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130
30421758443042175844Maria Heiling1N2026-01-013721 Valley Centre Dr., Ste. 500 San Diego CA US 92130
30421776653042177665Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3445691929009126K993819QWH-300 WRIST ARRAY COILMOS1999-12-03
3445691209117672K993776OBC-300 BREAST ARRAY COILMOS1999-12-03
3445692052297929K993477HRW WRIST ARRAY COILMOS1999-11-01
3445691144147427K993279QSC-085 SHOULDER ARRAY COILMOS1999-10-15
12361883942291K992533PHILIPS GYROSCAN INTERA (*)LNH1999-10-18
3445691883942291K992533PHILIPS GYROSCAN INTERA (*)LNH1999-10-18
12361856181893K991943MRGP OPTICAL TRACKING UNITLNH1999-08-23
12361204536826K991765SYNERGY SHOULDER COILMOS1999-08-02
3445691204536826K991765SYNERGY SHOULDER COILMOS1999-08-02
12361312791880K990423PHILIPS NICOL COLLIMATOR FAMILYIZW1999-03-15
12361360242724K984545RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMSIZI1999-02-25
12362025973855K983342MR GUIDED PROCEDURES (MRGP) BASIC PACKAGELHN1998-12-21
3445691456544812K983109MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANYMOS1998-10-06
3331651128069375K983069PHILIPS DUO DIAGNOSTOWB1998-11-02
12361819420165K982993PHILIPS OMNIDIAGNOSTOWB1998-09-29
12361302678259K982834RESTGRID PACKAGE/GYROSCAN NTLNH1998-10-29
12361726001784K982631PHILIPS TOMOSCAN CSJAK1998-10-06
12361435871691K980645PHILIPS GYROSCAN NT RELEASE 6 SERIESLNH1998-05-11
12361372719824K974844OUTLOOK SYSTEM ENHANCEMENT PACKAGELNH1998-03-10
12361060696248K973658DIFFUSION PACKAGE / GYROSCAN NTLNH1998-05-06
12361660447716K973482PHILIPS INTEGRIS V5000 AND BV5000IZI1997-11-10
12361691668906K971365PHILIPS INTEGRIS H5000IZI1997-05-14
3445691870862141K970868MODEL HNC NEUROVASCULAR ARRAY COILMOS1997-06-06
3445691021958305K964668MODELS EXL AND EXS EXTREMITY COIL SETMOS1997-02-18
12361654171480K964626EDGE/VISTA SYSTEM ENHANCEMENT PACKAGELNH1997-02-10
3331651828905146K964124PHILIPS COMPUTED RADIOGRAPHYLLZ1996-12-18
12361274159977K963990GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIESLNH1997-05-29
3445691904209257K961525ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)MOS1996-09-05
3445691479819954K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILSLNH1996-07-03
3445691645051704K954190MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COILMOS1995-11-20
12361310735967K953910PHILIPS BV 300 SERIESOXO1995-10-18
12361060318228K945945GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NTLNH1995-12-22
3445691157441157K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COILLNH1995-03-23
3445691949046115K944331MODEL 528GE SERIESLNH1995-01-25
3445691984169778K941025PHASED ARRAY BREAST COILLNH1994-06-08
12361325548563K940534GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)LNH1994-11-22
3445691299708266K934396QUADRATURE LOWER EXTREMITY COILLNH1993-11-24
12361069391269K925302PHILIPS INTEGRIS H/HM SYSTEMIZF1992-12-17
12361026364882K924082PHILIPS TOMOSCAN SR7000 CT SYSTEMSJAK1993-03-10
12361974714409K920793PHILIPS DSI SYSTEM RELEASE 3.2IZJ1992-07-17
12361558900592K911098PHILIPS URO DIAGNOST MRFIXR1991-07-03
12361395987162K910115PHILIPS BV-29 IMAGING SYSTEMOXO1991-02-20
12361365250594K904012PHILIPS INTEGRIS I 2000 SYSTEMJAA1990-11-29
12361352167342K903390MEDRAD MARK V-PLUS INJECTORDXT1990-09-26
3445691551463283K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0TMOS2026-07-30
3445691263583061K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0TMOS2026-07-24
1761221200374338K260519Smart Fit TorsoCardiac 1.5TMOS2026-03-20
3445691200374338K260519Smart Fit TorsoCardiac 1.5TMOS2026-03-20
3330141121055954K254205Zenition 30OWB2026-08-07
3445641121055954K254205Zenition 30OWB2026-08-07
3445691603757776K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS2026-01-14
3445641379404817K254186Azurion R3.1OWB2026-01-16
3445641916947522K253670SmartCT (R3.0 (L10))OWB2026-07-10
3445691482117333K253648Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including UpgradesLNH2026-02-23
3445641751793649K253614EchoNavigator R5.0QIH2026-03-17
1761221421649109K252992CT Rembra RT; CT Areta RT; CT RembraJAK2026-03-23
3445641639753993K251827Azurion R3.1OWB2025-10-24
3445691335643157K251808Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR SystemsLNH2025-07-11
3445691524345277K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemLNH2025-06-04
3445691620670065K243033dS Wrist coil 8ch 1.5TMOS2024-10-18
3445691015718330K242879dS Knee Coil 8ch 1.5TMOS2024-10-18
3445691865790355K242096dS FootAnkle Coil 8ch 1.5TMOS2024-08-12
3330142068722153K240224Zenition 90OWB2024-05-22
3445642068722153K240224Zenition 90OWB2024-05-22
3331651415089414K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA2024-01-11
3331651765842423K233678Radiography 7000 MIZL2024-02-14
3331651788957111K233662Radiography 7300 CKPR2024-06-13
1761222071723782K233600Smart Fit Knee 3.0TMOS2024-02-05
3445691244650848K23334816 Breast CoilMOS2023-10-24
3331651315616371K232910CombiDiagnost R90JAA2023-10-19
3445691967000664K232762dS Breast Coil 7ch 1.5TMOS2023-10-03
1761221048670297K232491CT 5300JAK2024-05-03
3330141095985298K232420Zenition 30OWB2024-02-16
3445641095985298K232420Zenition 30OWB2024-02-16
3445691326322693K232030Ingenia Elition R5.7.1 SP4 MR SystemsLNH2023-08-02
1761221104030356K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS2023-09-01
3445691104030356K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS2023-09-01
3445691954750056K230972Ingenia Elition and MR 7700 MR SystemsLNH2023-04-28
3445691925952403K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsLNH2023-04-06
3445691281012239K223442MR 5300 and MR 7700 R11 MR SystemsLNH2022-12-23
3445691705785894K2223258ch Wrist CoilMOS2022-08-31
3445691773826353K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOS2022-08-23
3445641588967553K221270EchoNavigator R4.0LLZ2022-05-31
3445691879347858K214081MRCAT Head & NeckMUJ2022-04-05
3445691226741137K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0TMOS2021-12-23
3445691205355048K213735dS Sentinelle Breast 16ch 1.5T CoilMOS2022-08-08
3445691413080404K213727dS Sentinelle Breast 16ch 3.0T CoilMOS2022-08-08
3445691573781842K213583Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR SystemsLNH2022-05-16
3445691860828491K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiLNH2022-03-03
3445691146844232K213351ds Head 32ch 3.0TMOS2021-10-29
1761221736796758K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS2021-12-01
3331651714820303K212837ProxiDiagnost N90JAA2021-09-21
3330141971433548K212813Zenition 70OWB2021-10-01
3445641971433548K212813Zenition 70OWB2021-10-01
3445691642428948K212673MR 5300LNH2021-11-19
1761221011240304K212441Philips Incisive CTJAK2022-04-27
12362030907899K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3TMOS2022-03-03
3331651944706471K210692DigitalDiagnostKPR2021-04-02
3330141254851779K203623StentBoost MobileOWB2021-04-05
3331651229650080K203087CombiDiagnost R90JAA2020-12-03
3331651785372338K202564DigitalDiagnost C90MQB2020-09-30
1761221688531227K201725DigitalDiagnost C50KPR2020-07-10
1761221337172247K201640DuraDiagnostKPR2020-07-09
3445641897551169K201583SmartCT R1.0OWB2021-02-09
12361555773957K201389Resoundant Acoustic Driver SystemLNH2020-07-10
3445641527780676K200917Azurion R2.1OWB2020-05-01
3445642041921842K200713EchoNavigatorLLZ2020-04-09
3445691043478736K193215Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR SystemsLNH2020-04-10
3445691541903923K193109MRCAT brainMUJ2020-01-24
3445691901490780K190461Achieva 1.5T, 3.0T and Intera 1.5T MR SystemsLNH2019-06-04
3330142043227571K183101Zenition 50OWB2018-12-31
3445642043227571K183101Zenition 50OWB2018-12-31
3445691925446475K183063Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR SystemsLNH2019-02-14
3330141804466435K183040Zenition 70OWB2018-12-06
3445641804466435K183040Zenition 70OWB2018-12-06
3331651328282187K182973DigitalDiagnost C90MQB2019-01-11
3445691142527253K182888MRCAT PelvisMUJ2019-04-30
1761221876290552K182529Xperius Ultrasound SystemIYN2018-10-23
12361197456236K181966SmartPerfusionOWB2018-08-17
3445641424755334K181830Azurion R2.0OWB2018-08-02

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS1082026-07-30
OWB692026-08-07
LNH692026-02-23
LLZ162022-05-31
JAK152026-03-23
IZI112013-05-21
KPR92024-06-13
JAA82024-01-11
MQB62020-09-30
MUJ42022-04-05
IYN42018-10-23
MWI42018-09-07
OXO32001-04-02
IZL22024-02-14
IYE22018-09-14
MUE22013-12-13
IZW22003-07-21
QIH12026-03-17
DQK12018-10-24
LHN11998-12-21
IZF11992-12-17
IZJ11992-07-17
IXR11991-07-03
DXT11990-09-26