FDA.reportPublic FDA data

Noelle Zuccarello

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96157823004084693Noelle Zuccarello1N2026-01-011001 Briggs Rd Mount Laurel NJ US 08054
30029946363002994636Noelle Zuccarello1N2026-01-011001 Briggs Rd Mount Laurel NJ US 08054
30036774173003677417Noelle Zuccarello1N2026-01-011001 Briggs Rd Mount Laurel NJ US 08054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
133201919339317K990948S575 INTRAORAL DOCKING DENTAL CAMERAEIA1999-04-21
133201654851568K983625S555 INTRAORAL DENTAL CAMERAEIA1999-01-11
133201364102841K973798S-357 VIDEO IMAGING SYSTEMFET1997-12-03
133201295393060K973796S-41 &41S VIDEO IMAGING SYSTEMGCJ1998-01-02
133201321499668K973795S-52 ELECTRONIC VIDEO LAPAROSCOPEGCJ1998-01-02
133201594270647K973794S-57 VIDEO IMAGING SYSTEMGCJ1998-01-02
133201663049885K972540S-357 VIDEO IMAGING SYSTEMFET1997-09-18
1172131288320748K231055x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology)EHD2023-12-28
133201057437202K223470C50NBL2023-12-14
1172131217140416K203374X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)MUH2021-02-05
1172131091261232K201382X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)OAS2020-11-18
1172131149350065K192165Acteon Imaging SuiteLLZ2020-02-11
1172131532908350K191719X-MIND TriumMUH2020-02-20
1172131755921410K180601Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)OAS2018-11-02
1172131912441558K1730413DIEMME RealGUIDELLZ2018-12-20
1172131179519421K162190Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)MUH2017-07-06
1172131719003950K160166X-MIND triumOAS2016-11-15
133201187511336K153367S698 Symbioz flowHIF2016-06-17
133201640192151K151053PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scannerMUH2015-07-31
1172132055915000K143703NICAL SMART MICRO CR system for intraoral dental imagesMUH2015-03-18
133201730958976K142995SOPIXMUH2015-08-17
133202052406154K140013SOPIX INSIDE, SOPIX2 INSIDEMUH2014-09-05
1172131675860447K133271OPTEO, VIDEOGRAPH HDMUH2014-04-28
1172131467207947K132378X-MIND UNITYEHD2014-05-30
1172131657788416K130109ENDOGRAPH DCEHD2013-08-01
133201025306227K121685SOPROCARENBL2013-03-12
1172131130727468K111152ROTOGRAPH EVO 3DMUH2011-07-22
133201532053406K103813SOPRO 281NTN2011-03-22
133201951334067K092583SOPROLIFENBL2010-01-13
133201896064395K092329SOPIX 2MUH2010-07-20
1172131232890788K090749ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191EHD2009-05-18
133201698154313K082796SOPRO 184 CAMERAGCJ2009-04-01
646211389922372K082116HEMOSTASYL PASTEMVL2008-12-17
133201633094490K080122SOPRO 670 ARTHROSCOPIC PUMPHRX2008-07-11
133201927335907K072912SOPRO 225 DUAL HALOGEN LIGHT SOURCEGCJ2007-11-16
133201171675541K070783SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATORHIF2007-12-13
133201741661742K070102SOPRO 162 CAMERAGCJ2007-02-20
646211803375832K053328BIOSPLINT SPLINTING RIBBONEBI2006-01-25
646212018018207K050180EXPA-SYLMVL2005-02-11
133201667104657K041050DIGORA OPTIME (OR DIGORA ONTIME)MUH2004-06-15
133201753557833K031593SOPRO 61DGCJ2003-09-16
133201909188985K020915SOPRO LIGHT SOURCES AND ACCESSORIESGCJ2002-06-14
133201599608904K020270SOPRO 367D 3CCD FULL DIGITAL ENDOSCOPY CAMERAGCJ2002-03-14
133202042221133K013090SOPRO 67D OPERATING ROOM CAMERAGCJ2001-12-13
133202012716363K012505SOPRO595 INTRA ORAL CAMERAEIA2001-10-05
133201650028872K000424S51D DIGITAL ENDOSCOPY CAMERAGCJ2000-03-31
133201351955985K000423S52D DIGITAL VIDEO LAPAROSCOPEGCJ2000-03-31
133201242872015K000422S57D DIGITAL OPERATING ROOM CAMERAGCJ2000-03-31
1172131455882016
646211093437830
133201128555770
133201154757225
133201199427236
133201433068755
133201714323072
133201804418370

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GCJ132009-04-01
MUH112021-02-05
EHD42023-12-28
NBL32023-12-14
OAS32020-11-18
EIA32001-10-05
LLZ22020-02-11
HIF22016-06-17
MVL22008-12-17
FET21997-12-03
NTN12011-03-22
HRX12008-07-11
EBI12006-01-25