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
30106852853010685285Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130
30168518253016851825Maria Heiling1N2026-01-013721 Valley Centre Dr. Ste. 500 San Diego CA US 92130
30335259863033525986Maria 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
30335272813033527281Maria 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
2884521209117672K993776OBC-300 BREAST ARRAY COILMOS1999-12-03
3445691209117672K993776OBC-300 BREAST ARRAY COILMOS1999-12-03
2884522052297929K993477HRW WRIST ARRAY COILMOS1999-11-01
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
1834761312791880K990423PHILIPS 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
3330101128069375K983069PHILIPS 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
2884521870862141K970868MODEL HNC NEUROVASCULAR ARRAY COILMOS1997-06-06
3445691870862141K970868MODEL HNC NEUROVASCULAR ARRAY COILMOS1997-06-06
3445691021958305K964668MODELS EXL AND EXS EXTREMITY COIL SETMOS1997-02-18
12361654171480K964626EDGE/VISTA SYSTEM ENHANCEMENT PACKAGELNH1997-02-10
3330101828905146K964124PHILIPS COMPUTED RADIOGRAPHYLLZ1996-12-18
12361274159977K963990GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIESLNH1997-05-29
2884521904209257K961525ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)MOS1996-09-05
3445691904209257K961525ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)MOS1996-09-05
2884521479819954K961366MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILSLNH1996-07-03
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
2884521157441157K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COILLNH1995-03-23
3445691157441157K945778PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COILLNH1995-03-23
3445691949046115K944331MODEL 528GE SERIESLNH1995-01-25
2884521984169778K941025PHASED ARRAY BREAST COILLNH1994-06-08
3445691984169778K941025PHASED ARRAY BREAST COILLNH1994-06-08
12361325548563K940534GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)LNH1994-11-22
2884521299708266K934396QUADRATURE LOWER EXTREMITY COILLNH1993-11-24
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
1761221200374338K260519Smart Fit TorsoCardiac 1.5TMOS2026-03-20
3445691200374338K260519Smart Fit TorsoCardiac 1.5TMOS2026-03-20
2884521603757776K254190dS 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
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
3331611482117333K253648Ingenia, 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
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
3331611524345277K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemLNH2025-06-04
3445691524345277K251397Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR SystemLNH2025-06-04
2884521620670065K243033dS Wrist coil 8ch 1.5TMOS2024-10-18
3445691620670065K243033dS Wrist coil 8ch 1.5TMOS2024-10-18
2884521015718330K242879dS Knee Coil 8ch 1.5TMOS2024-10-18
3445691015718330K242879dS Knee Coil 8ch 1.5TMOS2024-10-18
2884521865790355K242096dS FootAnkle Coil 8ch 1.5TMOS2024-08-12
3445691865790355K242096dS FootAnkle Coil 8ch 1.5TMOS2024-08-12
3330142068722153K240224Zenition 90OWB2024-05-22
3445642068722153K240224Zenition 90OWB2024-05-22
3330101415089414K233945ProxiDiagnost N90 / Precision CRF (706110, 706400)JAA2024-01-11
3330101765842423K233678Radiography 7000 MIZL2024-02-14
3330101788957111K233662Radiography 7300 CKPR2024-06-13
1761222071723782K233600Smart Fit Knee 3.0TMOS2024-02-05
2884521244650848K23334816 Breast CoilMOS2023-10-24
3445691244650848K23334816 Breast CoilMOS2023-10-24
3330101315616371K232910CombiDiagnost R90JAA2023-10-19
2884521967000664K232762dS Breast Coil 7ch 1.5TMOS2023-10-03
3445691967000664K232762dS Breast Coil 7ch 1.5TMOS2023-10-03
1761221048670297K232491CT 5300JAK2024-05-03
3330141095985298K232420Zenition 30OWB2024-02-16
3445641095985298K232420Zenition 30OWB2024-02-16
3331611326322693K232030Ingenia Elition R5.7.1 SP4 MR SystemsLNH2023-08-02
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
3331611954750056K230972Ingenia Elition and MR 7700 MR SystemsLNH2023-04-28
3445691954750056K230972Ingenia Elition and MR 7700 MR SystemsLNH2023-04-28
3331611925952403K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsLNH2023-04-06
3445691925952403K223458Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR SystemsLNH2023-04-06
3331611281012239K223442MR 5300 and MR 7700 R11 MR SystemsLNH2022-12-23
3445691281012239K223442MR 5300 and MR 7700 R11 MR SystemsLNH2022-12-23
2884521705785894K2223258ch Wrist CoilMOS2022-08-31
3445691705785894K2223258ch Wrist CoilMOS2022-08-31
2884521773826353K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOS2022-08-23
3445691773826353K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOS2022-08-23
3445641588967553K221270EchoNavigator R4.0LLZ2022-05-31
3331611879347858K214081MRCAT Head & NeckMUJ2022-04-05
3445691879347858K214081MRCAT Head & NeckMUJ2022-04-05
2884521226741137K213766dS 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
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
2884521205355048K213735dS Sentinelle Breast 16ch 1.5T CoilMOS2022-08-08
3445691205355048K213735dS Sentinelle Breast 16ch 1.5T CoilMOS2022-08-08
2884521413080404K213727dS Sentinelle Breast 16ch 3.0T 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
3331611860828491K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiLNH2022-03-03
3445691860828491K213516Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi NudcleiLNH2022-03-03
2884521146844232K213351ds Head 32ch 3.0TMOS2021-10-29
3445691146844232K213351ds Head 32ch 3.0TMOS2021-10-29
1761221736796758K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS2021-12-01
3330101714820303K212837ProxiDiagnost N90JAA2021-09-21
3330141971433548K212813Zenition 70OWB2021-10-01
3445641971433548K212813Zenition 70OWB2021-10-01
3331611642428948K212673MR 5300LNH2021-11-19
3445691642428948K212673MR 5300LNH2021-11-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MOS1632026-03-20
LNH1002026-02-23
OWB672026-01-16
LLZ182022-05-31
JAK152026-03-23
IZI112013-05-21
KPR92024-06-13
JAA82024-01-11
MUJ82022-04-05
MQB62020-09-30
MUE52013-12-13
MWI42018-09-07
IYN32016-11-16
IZW32003-07-21
OXO32001-04-02
IZL22024-02-14
IYE22018-09-14
QIH12026-03-17
DQK12018-10-24
LHN11998-12-21
IZF11992-12-17
IZJ11992-07-17
IXR11991-07-03
DXT11990-09-26