Gammex Inc

FDA Filings

This page includes the latest FDA filings for Gammex 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: 2182882
• FEI Number: 2182882
• Name: GAMMEX, INC.
• Owner & Operator: GAMMEX, INC.
• Contact Address: 7600 Discovery Dr. --; Middleton WI 53562 US
• Official Correspondent:
  • Jeff - Shaw
  • x-608-8287000-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 7600 DISCOVERY DRIVE ; MIDDLETON, WI 53562 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID B136159A0 GAMMEX, INC.	Phototimer Consistency Tools	2021-12-09
GUDID B136AP60 GAMMEX, INC.	Sun Nuclear	2021-09-06
GUDID B1364870 GAMMEX, INC.	Sun Nuclear B200 Bone Mineral	2021-09-06
GUDID B1364850 GAMMEX, INC.	Sun Nuclear LN-450 Lung TMM	2021-09-06
GUDID B1364840 GAMMEX, INC.	Sun Nuclear CB2 + 30% CaCO3 TMM	2021-09-06
GUDID B1364830 GAMMEX, INC.	Sun Nuclear CB2 + 10% CaCO3 TMM	2021-09-06
GUDID B1364820 GAMMEX, INC.	Sun Nuclear LV1 Liver TMM	2021-09-06
GUDID B1364810 GAMMEX, INC.	Sun Nuclear BRN-SR2 Brain	2021-09-06
GUDID B1364800 GAMMEX, INC.	Sun Nuclear CB2 + 50% CaCO3	2021-09-06
GUDID B136468BHP0 GAMMEX, INC.	Sun Nuclear CT Dose Index Phantom	2021-09-06
GUDID B136468BH0 GAMMEX, INC.	Sun Nuclear CT Dose Index	2021-09-06
GUDID B1364570 GAMMEX, INC.	Sun Nuclear Original Solid Water	2021-09-06
GUDID B1364560 GAMMEX, INC.	Sun Nuclear IB3 Inner Bone	2021-09-06
GUDID B1364550 GAMMEX, INC.	Sun Nuclear LN-300 Lung	2021-09-06
GUDID B1364540 GAMMEX, INC.	Sun Nuclear BR12 Breast	2021-09-06
GUDID B1364530 GAMMEX, INC.	Sun Nuclear BR12 Breast	2021-09-06
GUDID B1364520 GAMMEX, INC.	Sun Nuclear MS11 Muscle	2021-09-06
GUDID B1364510 GAMMEX, INC.	Sun Nuclear CT Solid Water	2021-09-06
GUDID B1364500 GAMMEX, INC.	Sun Nuclear SB3 Cortical Bone	2021-09-06
GUDID B136411LE0 GAMMEX, INC.	Sun Nuclear Tissue Mimicking Phantom	2021-09-06
GUDID B136403GSLE0 GAMMEX, INC.	Sun Nuclear Sono403 Multi-Purpose Phantom SCG	2021-09-06
GUDID B13628230 GAMMEX, INC.	Sun Nuclear MultiPHAN Phantom Kit	2021-09-06
GUDID B1362000 GAMMEX, INC.	Sun Nuclear Low Contrast Test Tool	2021-09-06
GUDID B136159ABR0 GAMMEX, INC.	Sun Nuclear Phototimer Consistency Tools	2021-09-06
GUDID B13614720 GAMMEX, INC.	Sun Nuclear Multi-Energy CT Phantom	2021-09-06
GUDID B13614670 GAMMEX, INC.	Sun Nuclear Advanced Electron Density Phantom	2021-09-06
GUDID B13614640 GAMMEX, INC.	Sun Nuclear Advanced iqModule	2021-09-06
GUDID B136115H0 GAMMEX, INC.	Sun Nuclear 115H Half Value Layer Attenuator Set	2021-09-06
GUDID B1361150 GAMMEX, INC.	Sun Nuclear 115A Half Value Layer Attenuator Set	2021-09-06
GUDID B136161B0 GAMMEX, INC.	Sun Nuclear Collimator Test Tool Stainless Steel	2021-09-03
GUDID B136156D0 GAMMEX, INC.	Sun Nuclear Mammo 156D Stereo Phantom	2021-09-03
GUDID B1364640 GAMMEX, INC.	Sun Nuclear CT ACR 464 Phantom	2021-09-02
GUDID B1365570 GAMMEX, INC.	Sun Nuclear	2021-04-13
GUDID B1364670 GAMMEX, INC.	Sun Nuclear CT Electron Density Phantom	2021-03-22
GUDID B1361560 GAMMEX, INC.	Sun Nuclear Mammo 156 Phantom	2021-03-22
GUDID B136MLR350MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 805876	2021-02-02
GUDID B136MLR3500 GAMMEX, INC.	Sun Nuclear MICRO+ 805723	2021-02-02
GUDID B136MLR300MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 805896	2021-02-02
GUDID B136MLR3000 GAMMEX, INC.	Sun Nuclear MICRO+ 805722	2021-02-02
GUDID B136MLR2000 GAMMEX, INC.	Sun Nuclear MICRO 805705	2021-02-02
GUDID B136MLR1500 GAMMEX, INC.	Sun Nuclear MICRO 805706	2021-02-02
GUDID B136MLG350MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 805877	2021-02-02
GUDID B136MLG3500 GAMMEX, INC.	Sun Nuclear MICRO+ 805725	2021-02-02
GUDID B136MLG300MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 805897	2021-02-02
GUDID B136MLG3000 GAMMEX, INC.	Sun Nuclear MICRO+ 805724	2021-02-02
GUDID B136MLG2000 GAMMEX, INC.	Sun Nuclear MICRO 805707	2021-02-02
GUDID B136MLG1500 GAMMEX, INC.	Sun Nuclear MICRO 805708	2021-02-02
GUDID B136MLB350MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 808878	2021-02-02
GUDID B136MLB3500 GAMMEX, INC.	Sun Nuclear MICRO+ 805727	2021-02-02
GUDID B136MLB300MR0 GAMMEX, INC.	Sun Nuclear MICRO+ MR 805898	2021-02-02
GUDID B136MLB3000 GAMMEX, INC.	Sun Nuclear MICRO+	2021-02-02
GUDID B136MLB2000 GAMMEX, INC.	Sun Nuclear MICRO 805709	2021-02-02
GUDID B136MLB1500 GAMMEX, INC.	Sun Nuclear MICRO 805710	2021-02-02
GUDID B1365000R0 GAMMEX, INC.	CT Sim+ 805655	2019-10-02
GUDID B1365000G0 GAMMEX, INC.	CT Sim+ 805658	2019-10-02
GUDID B1365000B0 GAMMEX, INC.	CT Sim+ 805659	2019-10-02
GUDID B1363000R0 GAMMEX, INC.	CT Sim+ 805639	2019-10-02
GUDID B1363000G0 GAMMEX, INC.	CT Sim+ 805652	2019-10-02
GUDID B1363000B0 GAMMEX, INC.	CT Sim+ 805657	2019-10-02
GUDID B1361000RRC0 GAMMEX, INC.	CT Sim+ 805757	2019-10-02
GUDID B1361000R0 GAMMEX, INC.	CT Sim+ 805653	2019-10-02
GUDID B1361000GRC0 GAMMEX, INC.	CT Sim+ 805758	2019-10-02
GUDID B1361000G0 GAMMEX, INC.	CT Sim+ 805654	2019-10-02
GUDID B1361000BRC0 GAMMEX, INC.	CT Sim+ 805759	2019-10-02
GUDID B1361000B0 GAMMEX, INC.	CT Sim+ 805656	2019-10-02
GUDID B136A5000A0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136A4110G0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136A4100G0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136A4010A0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136A3100G0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136A3000A0 GAMMEX, INC.	CT Sim	2019-09-26
GUDID B136RC10000 GAMMEX, INC.	RapidCheck	2018-12-31
PMN K152303 GAMMEX, INC.	CT Sim Laser System	2015-09-11
PMN K954564 GAMMEX, INC.	PID-1 PRECISION INTELLIGENT DOSIMETER	1996-04-22
PMN K953514 GAMMEX, INC.	COURIER II	1995-10-07
LHO GAMMEX, INC.	RC-1000 RapidCheck	1994-05-23
LHO GAMMEX, INC.	Mammo 156 Phantom	1994-05-23
LHO GAMMEX, INC.	Mammo 145 FFDM Phantom	1994-05-23
LHO GAMMEX, INC.	M3DP Mammo 3D Performance Kit	1994-05-23
LHO GAMMEX, INC.	Edge Tool	1994-05-23
LHO GAMMEX, INC.	610 Neonatal Chest Phantom	1994-05-23
LHO GAMMEX, INC.	557 HE Solid Water	1994-05-23
LHO GAMMEX, INC.	487 B200 Bone Mineral	1994-05-23
LHO GAMMEX, INC.	485 LN 450 Lung	1994-05-23
LHO GAMMEX, INC.	484 CB2 + 30% CACO3	1994-05-23
LHO GAMMEX, INC.	483 CB2 + 10% CACO3	1994-05-23
LHO GAMMEX, INC.	482 LV1 Liver	1994-05-23
LHO GAMMEX, INC.	481 BRN-SR2 Brain	1994-05-23
LHO GAMMEX, INC.	480 CB2 + 50% CACO3	1994-05-23
LHO GAMMEX, INC.	468 CTDI Phantom	1994-05-23
LHO GAMMEX, INC.	467 Tissue Characterization Phantom	1994-05-23
LHO GAMMEX, INC.	464 CT ACR Accreditation Phantom	1994-05-23
LHO GAMMEX, INC.	458 Calibration Check Phantom	1994-05-23
LHO GAMMEX, INC.	457 Original Solid Water	1994-05-23
LHO GAMMEX, INC.	456 IB3 Inner Bone	1994-05-23
LHO GAMMEX, INC.	455 LN-300 Lung	1994-05-23
LHO GAMMEX, INC.	454 BR12 Breast	1994-05-23
LHO GAMMEX, INC.	453 AP6 Fat	1994-05-23
LHO GAMMEX, INC.	452 MS11 Muscle	1994-05-23
LHO GAMMEX, INC.	451 CT Solid Water	1994-05-23
LHO GAMMEX, INC.	450 SB3 Cortical Bone	1994-05-23
LHO GAMMEX, INC.	443 Daily Laser and Light Field Plate	1994-05-23
LHO GAMMEX, INC.	442R Isocentric Rotation Plate	1994-05-23
LHO GAMMEX, INC.	440 Couch/Laser Alignment Tool	1994-05-23
LHO GAMMEX, INC.	432 CT Perfusion Phantom	1994-05-23
LHO GAMMEX, INC.	430 Beam Alignment Test Instrument	1994-05-23
LHO GAMMEX, INC.	419TG Precision Ultrasound Transducer Guide	1994-05-23
LHO GAMMEX, INC.	410 Multipurpose Accreditation Phantom	1994-05-23
LHO GAMMEX, INC.	3853 Mercury Phantom	1994-05-23
LHO GAMMEX, INC.	2823 Sun Nuclear MultiPHAN	1994-05-23
LHO GAMMEX, INC.	2376 CESM Phantom	1994-05-23
LHO GAMMEX, INC.	200 Low Contrast Test Tool	1994-05-23
LHO GAMMEX, INC.	179 Artifact Identification Phantom	1994-05-23
LHO GAMMEX, INC.	175 Universal Test Stand	1994-05-23
LHO GAMMEX, INC.	170NJ Radiographic Survey Phantom	1994-05-23
LHO GAMMEX, INC.	165SI Modular DBT Phantom for Breast Tomosynthesis	1994-05-23
LHO GAMMEX, INC.	165S Modular DBT Phantom for Breast Tomosynthesis	1994-05-23
LHO GAMMEX, INC.	163-DIG Digital Compression Scale	1994-05-23
LHO GAMMEX, INC.	163 Breast Compression Test Device	1994-05-23
LHO GAMMEX, INC.	162B Collimator and Beam Alignment Test Tools	1994-05-23
LHO GAMMEX, INC.	162A Beam Alignment Test Tool	1994-05-23
LHO GAMMEX, INC.	161B Collimator and Beam Alignment Test Tools	1994-05-23
LHO GAMMEX, INC.	159A-BR Phototimer Consistency Tool	1994-05-23
LHO GAMMEX, INC.	159A Phototimer Consistency Tool	1994-05-23
LHO GAMMEX, INC.	157A Mammographic Film/Screen Contact Test Tool	1994-05-23
LHO GAMMEX, INC.	156D Stereotactic Mammographic Accreditation Phantom	1994-05-23
LHO GAMMEX, INC.	1553 HE General Adipose	1994-05-23
LHO GAMMEX, INC.	150K Mammographic DCF Test Tool	1994-05-23
LHO GAMMEX, INC.	1482 HE Liver	1994-05-23
LHO GAMMEX, INC.	1481 HE Brain	1994-05-23
LHO GAMMEX, INC.	1472 Multi-Energy CT Phantom	1994-05-23
LHO GAMMEX, INC.	1467 Cone-Beam CT Electron Density Phantom	1994-05-23
LHO GAMMEX, INC.	1467 Advanced Electron Density Phantom	1994-05-23
LHO GAMMEX, INC.	1466 HE Breast Glandular	1994-05-23
LHO GAMMEX, INC.	1464 Advanced iqModules	1994-05-23
LHO GAMMEX, INC.	1459 HE Blood	1994-05-23
LHO GAMMEX, INC.	1456 HE Inner Bone	1994-05-23
LHO GAMMEX, INC.	1454 HE Breast 50:50	1994-05-23
LHO GAMMEX, INC.	1453 HE Breast Adipose	1994-05-23
LHO GAMMEX, INC.	1451 HE CT Solid Water	1994-05-23
LHO GAMMEX, INC.	1450 HE Cortical Bone	1994-05-23
LHO GAMMEX, INC.	144 Grid Alignment Test Tool	1994-05-23
LHO GAMMEX, INC.	143D Film Screen Test Tools	1994-05-23
LHO GAMMEX, INC.	142D Film Screen Test Tools	1994-05-23
LHO GAMMEX, INC.	141H High Contrast Resolution Test Tools	1994-05-23
LHO GAMMEX, INC.	141 High Contrast Resolution Test Tool	1994-05-23
LHO GAMMEX, INC.	132 Tomographic Test Tool	1994-05-23
LHO GAMMEX, INC.	118 Mammographic Aluminum Stepwedge	1994-05-23
LHO GAMMEX, INC.	117 Radiographic Aluminum Stepwedge	1994-05-23
LHO GAMMEX, INC.	116 Pure Copper Half Value Layer Attenuator Set	1994-05-23
LHO GAMMEX, INC.	115H Half Value Layer Attenuator Set	1994-05-23
LHO GAMMEX, INC.	115A Half Value Layer Attenuator Set	1994-05-23
LHO GAMMEX, INC.	1151 Radiographic Contrast/Detail Phantom	1994-05-23
LHO GAMMEX, INC.	112B Focal Spot Test Tool	1994-05-23
LHO GAMMEX, INC.	1083 - MapPHAN	1994-05-23
IWE GAMMEX, INC.	Micro+ Fixed Laser System	1992-08-04
IWE GAMMEX, INC.	Micro Fixed Laser System	1992-08-04
IWE GAMMEX, INC.	CT Sim+ Laser Alignment System	1992-08-04
IWE GAMMEX, INC.	CT Sim Laser Alignment System	1992-08-04
IXG GAMMEX, INC.	416 Sono TE	1991-12-23
IXG GAMMEX, INC.	408 LE Spherical Lesion Phantom	1991-12-23
IXG GAMMEX, INC.	406 LE Dual Attenuation Phantom	1991-12-23
IXG GAMMEX, INC.	405 GSX LE Precision Resolution Grey Scale Phantom	1991-12-23
IXG GAMMEX, INC.	404 LE Precision Small Parts Grey Scale Phantom	1991-12-23
IXG GAMMEX, INC.	404 GS LE Precision Small Parts Grey Scale Phantom	1991-12-23
IXG GAMMEX, INC.	403 LE Precision Multi-Purpose Grey Scale Phantom	1991-12-23
IXG GAMMEX, INC.	1430 Mini Doppler Flow System	1991-12-23
IXG GAMMEX, INC.	1425B Doppler Flow System	1991-12-23

Related Finance Registrations

NCAGE Code	0Y5N8	GAMMEX, INC.
NCAGE Code	8W583	GAMMEX INC
CAGE Code	0Y5N8	GAMMEX, INC.
CAGE Code	8W583	GAMMEX INC
S.A.M. Registration	0Y5N8 [157308230]	GAMMEX, INC.
DUNS	157308230	GAMMEX, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019040838121	Shanghai ,China (Mainland) -> Los Angeles, California	ACRYLIC SHEET	1 PKG