Standard Imaging Inc

FDA Filings

This page includes the latest FDA filings for Standard Imaging Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 2184007
• FEI Number: 1000115748
• Name: STANDARD IMAGING, INC.
• Owner & Operator: STANDARD IMAGING, INC.
• Contact Address: 3120 DEMING WAY --; Middleton WI 53562 US
• Official Correspondent:
  • Caleb B Jung
  • x-608-8310025-7872
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3120 DEMING WAY ; MIDDLETON, WI 53562 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00850019946543 STANDARD IMAGING INC.	Standard Imaging IMSure 3D 91365	2023-12-07
GUDID 00866562000298 STANDARD IMAGING INC.	Standard Imaging QA Pilot 91348	2023-06-30
GUDID 00866562000281 STANDARD IMAGING INC.	Standard Imaging StructSure Software 91340	2023-06-30
GUDID 00866562000274 STANDARD IMAGING INC.	Standard Imaging RAy Software 91336	2023-06-30
GUDID 00850019946604 STANDARD IMAGING INC.	Standard Imaging IMSure 3D QA Software 91355	2023-06-30
GUDID 00850019946598 STANDARD IMAGING INC.	Standard Imaging Exradin P11 Ion Chamber 92703	2023-06-30
GUDID 00850019946581 STANDARD IMAGING INC.	Standard Imaging Exradin A10 Ion Chamber 92702	2023-06-30
GUDID 00850019946574 STANDARD IMAGING INC.	Standard Imaging Reconstruction Jig Small 91285	2023-06-30
GUDID 00850019946567 STANDARD IMAGING INC.	Standard Imaging Reconstruction Jig Large 91280	2023-06-30
GUDID 00850019946550 STANDARD IMAGING INC.	Standard Imaging IMRT Dose Verification Phantom 91230	2023-06-30
GUDID 00850019946536 STANDARD IMAGING INC.	Standard Imaging Winston Lutz Cube Phantom 91345	2023-06-30
GUDID 00850019946529 STANDARD IMAGING INC.	Standard Imaging Stereotactic Dose Verification Phantom 91250	2023-06-30
GUDID 00850019946512 STANDARD IMAGING INC.	Standard Imaging MIMI Phantom 91240	2023-06-30
GUDID 00850019946505 STANDARD IMAGING INC.	Standard Imaging Lucy 3D QA Phantom 91210	2023-06-30
GUDID 00850019946499 STANDARD IMAGING INC.	Standard Imaging TomoScanner 91750	2023-06-30
GUDID 00850019946482 STANDARD IMAGING INC.	Standard Imaging Exradin W1 Scintillator 92739	2023-06-30
GUDID 00850019946475 STANDARD IMAGING INC.	Standard Imaging Exradin D1H Diode Detector 92741	2023-06-30
GUDID 00850019946468 STANDARD IMAGING INC.	Standard Imaging Exradin D1V Diode Detector 92740	2023-06-30
GUDID 00850019946451 STANDARD IMAGING INC.	Standard Imaging Exradin A12SMR Ion Chamber 92905	2023-06-30
GUDID 00850019946444 STANDARD IMAGING INC.	Standard Imaging Exradin A12MR Ion Chamber 92904	2023-06-30
GUDID 00850019946437 STANDARD IMAGING INC.	Standard Imaging Exradin A19MR Ion Chamber 92903	2023-06-30
GUDID 00850019946420 STANDARD IMAGING INC.	Standard Imaging Exradin A28MR Ion Chamber 92902	2023-06-30
GUDID 00850019946413 STANDARD IMAGING INC.	Standard Imaging Exradin A26MR Ion Chamber 92901	2023-06-30
GUDID 00850019946406 STANDARD IMAGING INC.	Standard Imaging Exradin A1SLMR Ion Chamber 92900	2023-06-30
GUDID 00850019946390 STANDARD IMAGING INC.	Standard Imaging Exradin A28 Ion Chamber 92749	2023-06-30
GUDID 00850019946383 STANDARD IMAGING INC.	Standard Imaging Exradin A26 Ion Chamber 92746	2023-06-30
GUDID 00850019946376 STANDARD IMAGING INC.	Standard Imaging Exradin M2 Ion Chamber with Gas Flow 92742	2023-06-30
GUDID 00850019946369 STANDARD IMAGING INC.	Standard Imaging Exradin A8 Ion Chamber 92737	2023-06-30
GUDID 00850019946352 STANDARD IMAGING INC.	Standard Imaging Exradin A20 Ion Chamber 92736	2023-06-30
GUDID 00850019946345 STANDARD IMAGING INC.	Standard Imaging Exradin A19 Ion Chamber 92734	2023-06-30
GUDID 00850019946338 STANDARD IMAGING INC.	Standard Imaging Exradin A18 Ion Chamber 92729	2023-06-30
GUDID 00850019946321 STANDARD IMAGING INC.	Standard Imaging Exradin A16 Ion Chamber 92726	2023-06-30
GUDID 00850019946314 STANDARD IMAGING INC.	Standard Imaging Exradin A12S Ion Chamber 92725	2023-06-30
GUDID 00850019946307 STANDARD IMAGING INC.	Standard Imaging Exradin A5 Ion Chamber 92724	2023-06-30
GUDID 00850019946291 STANDARD IMAGING INC.	Standard Imaging Exradin A14SL Ion Chamber 92723	2023-06-30
GUDID 00850019946284 STANDARD IMAGING INC.	Standard Imaging Exradin A1SL Ion Chamber 92722	2023-06-30
GUDID 00850019946277 STANDARD IMAGING INC.	Standard Imaging Exradin T2 Ion Chamber with Gas Flow 92743	2023-06-30
GUDID 00850019946260 STANDARD IMAGING INC.	Standard Imaging DoseView 1D 70800	2023-06-30
GUDID 00850019946253 STANDARD IMAGING INC.	Standard Imaging Exradin A3 Ion Chamber 92717	2023-06-30
GUDID 00850019946246 STANDARD IMAGING INC.	Standard Imaging Exradin A6 Ion Chamber 92716	2023-06-30
GUDID 00850019946239 STANDARD IMAGING INC.	Standard Imaging Exradin A4 Ion Chamber 92715	2023-06-30
GUDID 00850019946222 STANDARD IMAGING INC.	Standard Imaging TomoElectrometer 90016	2023-06-30
GUDID 00850019946215 STANDARD IMAGING INC.	Standard Imaging Exradin A14 Ion Chamber 92711	2023-06-30
GUDID 00850019946208 STANDARD IMAGING INC.	Standard Imaging Exradin A11TW Ion Chamber 92708	2023-06-30
GUDID 00850019946192 STANDARD IMAGING INC.	Standard Imaging Exradin A1 Ion Chamber 92705	2023-06-30
GUDID 00850019946185 STANDARD IMAGING INC.	Standard Imaging Exradin A11 Ion Chamber 92701	2023-06-30
GUDID 00850019946178 STANDARD IMAGING INC.	Standard Imaging Exradin A12 Ion Chamber 92700	2023-06-30
GUDID 00850019946161 STANDARD IMAGING INC.	Standard Imaging Exradin A101 Ion Chamber 92680	2023-06-30
GUDID 00850019946154 STANDARD IMAGING INC.	Standard Imaging Exradin A17 Ion Chamber 92675	2023-06-30
GUDID 00850019946147 STANDARD IMAGING INC.	Standard Imaging Exradin Magna 650 Ion Chamber 92650	2023-06-30
GUDID 00850019946130 STANDARD IMAGING INC.	Standard Imaging Exradin Magna 600 92600	2023-06-30
GUDID 00850019946123 STANDARD IMAGING INC.	Standard Imaging QA StereoChecker 91349	2023-06-30
GUDID 00850019946116 STANDARD IMAGING INC.	Standard Imaging QA BeamChecker Plus 90501	2023-06-30
GUDID 00850019946109 STANDARD IMAGING INC.	Standard Imaging MAX SD 90030	2023-06-30
GUDID 00850019946093 STANDARD IMAGING INC.	Standard Imaging SuperMAX Electrometer 90018	2023-06-30
GUDID 00850019946086 STANDARD IMAGING INC.	Standard Imaging MAX 4000 Plus Electrometer 90020	2023-06-30
GUDID 00850019946079 STANDARD IMAGING INC.	Standard Imaging CDX 2000B Electrometer 90001	2023-06-30
GUDID 00850019946062 STANDARD IMAGING INC.	Standard Imaging Needle Cradle 90095	2023-06-30
GUDID 00850019946048 STANDARD IMAGING INC.	Standard Imaging Needle Loading Shield 90070	2023-06-30
GUDID 00850019946031 STANDARD IMAGING INC.	Standard Imaging Seed Slider 90090	2023-06-30
MWW STANDARD IMAGING, INC.	Radiation Analyzer Film Dosimetry Software	2020-01-02
GUDID 00866562000250 STANDARD IMAGING INC.	Standard Imaging IVB 1000 Well Chamber 90009	2018-07-06
GUDID 00866562000236 STANDARD IMAGING INC.	Standard Imaging PIPSpro Software 91309	2018-07-06
GUDID 00866562000229 STANDARD IMAGING INC.	Standard Imaging IMSure QA Software 91326	2018-07-06
GUDID 00866562000267 STANDARD IMAGING INC.	Standard Imaging LinacView Software 91330	2018-03-29
GUDID 00866562000243 STANDARD IMAGING INC.	Standard Imaging Adaptivo 91350	2018-03-29
GUDID 00866562000212 STANDARD IMAGING INC.	Standard Imaging HDR 1000 Plus 90008	2018-03-29
GUDID 00866562000205 STANDARD IMAGING INC.	Standard Imaging DoseView 3D 92260	2018-03-29
PMN K103193 | IYE STANDARD IMAGING, INC.	DoseView 3D	2015-05-13
PMN K103193 STANDARD IMAGING, INC.	DOSEVIEW 3D	2010-12-27
PMN K082773 STANDARD IMAGING, INC.	STANDARD IMAGING IMSURE BRACHY QA SOFTWARE, MODEL 91331	2008-11-19
PMN K060532 | KXK STANDARD IMAGING, INC.	HDR 1000 Plus with Xoft Insert	2007-10-15
PMN K060532 | JAQ STANDARD IMAGING, INC.	HDR 1000 Plus with Xoft Insert	2007-10-15
PMN K042733 | LMD STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K042733 | LMB STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K042733 | LLZ STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K042733 | LHO STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K042733 | IYE STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K042733 | IXG STANDARD IMAGING, INC.	PIPSPro Software,	2007-10-15
PMN K040688 | MUJ STANDARD IMAGING, INC.	IMSure QA	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	PIPSpro	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	LinacView	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	IMSure QA	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	IMSure Brachy	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	DoseView 3D	2007-10-15
PMN K031975 | IYE STANDARD IMAGING, INC.	Adaptivo	2007-10-15
PMN K001825 | JAQ STANDARD IMAGING, INC.	PT 1000 Well Chamber	2007-10-15
PMN K001825 | JAQ STANDARD IMAGING, INC.	IVB 1000 Well Chamber	2007-10-15
PMN K001825 | JAQ STANDARD IMAGING, INC.	HDR 1000 Plus Well Chamber	2007-10-15
PMN K001825 | IWJ STANDARD IMAGING, INC.	PT 1000 Well Chamber	2007-10-15
PMN K001825 | IWJ STANDARD IMAGING, INC.	IVB 1000 Well Chamber	2007-10-15
PMN K001825 | IWJ STANDARD IMAGING, INC.	HDR 1000 Plus Well Chamber	2007-10-15
PMN K060532 STANDARD IMAGING, INC.	HDR 1000 PLUS WELL CHAMBER, MODEL 90008	2006-04-11
PMN K042733 STANDARD IMAGING, INC.	STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM	2004-11-15
PMN K040688 STANDARD IMAGING, INC.	STANDARD IMAGING E.IMRT CALCULATOR	2004-05-11
IWE STANDARD IMAGING, INC.	Patient Re-alignment Tool	2002-01-23
IWE STANDARD IMAGING, INC.	In-air Comparison Jig	2002-01-23
PMN K013548 STANDARD IMAGING, INC.	STANDARD IMAGING IVB 1000 WELL CHAMBER	2001-11-09
IXG STANDARD IMAGING, INC.	Virtual Water	2001-06-12
IXG STANDARD IMAGING, INC.	Stereotactic Dose Verification Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	Reconstruction Jig	2001-06-12
IXG STANDARD IMAGING, INC.	RGP Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	QCkVR-1 Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	QCkV-1 Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	QC-3 Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	Mini Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	MIMI Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	LUCY 3D QA Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	IVB Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	IMRT Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	FC-2 Phantom	2001-06-12
IXG STANDARD IMAGING, INC.	Blue Water	2001-06-12
IXG STANDARD IMAGING, INC.	ACE Phantom	2001-06-12
PMN K002833 STANDARD IMAGING, INC.	MODIFICATION TO STANDARD IMAGING PT 1000 ION CHAMBER	2000-09-28
PMN K001825 STANDARD IMAGING, INC.	STANDARD IMAGING HDR 1000 PLUS ION CHAMBER; STANDARD IMAGING IVB 1000 ION CHAMBER	2000-08-02
HTC STANDARD IMAGING, INC.	SEED VAC	2000-03-22
HTC STANDARD IMAGING, INC.	DIDDLER	2000-03-22
KPY STANDARD IMAGING, INC.	Multiple Needle Loading Shields	1996-03-22
PMN K940539 STANDARD IMAGING, INC.	STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM	1994-03-16
PMN K922554 STANDARD IMAGING, INC.	STANDARD IMAGING HDR 1000 ION CHAMBER	1992-08-24
LHO STANDARD IMAGING, INC.	Tomo Scanner	1992-06-24
LHO STANDARD IMAGING, INC.	Tomo Electrometer	1992-06-24
LHO STANDARD IMAGING, INC.	SuperMAX	1992-06-24
LHO STANDARD IMAGING, INC.	QA StereoChecker	1992-06-24
LHO STANDARD IMAGING, INC.	QA BeamChecker Plus	1992-06-24
LHO STANDARD IMAGING, INC.	MAX SD	1992-06-24
LHO STANDARD IMAGING, INC.	MAX 4000 Plus	1992-06-24
LHO STANDARD IMAGING, INC.	Luthman	1992-06-24
LHO STANDARD IMAGING, INC.	Exradin	1992-06-24
LHO STANDARD IMAGING, INC.	DoseView 1D	1992-06-24
LHO STANDARD IMAGING, INC.	CDX 2000B	1992-06-24

Related Finance Registrations

NCAGE Code	01TC3	STANDARD IMAGING INC.
CAGE Code	01TC3	STANDARD IMAGING INC.
S.A.M. Registration	01TC3 [788084705]	STANDARD IMAGING INC.