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System, X-Ray, Mammographic

FDA product code IZH · 175 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.1710
Review panel: RA
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-08-03 – 2021-07-14

IZH 1994-01-28

LORAD M-III

Applicant Lorad Corp.

K number K934625

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IZH 1993-09-20

CHENOWETH-FRANK RADIOPATHOLOGICAL GRID

Applicant Cook, Inc.

K number K933754

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IZH 1993-08-23

AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS

Applicant Elscint, Inc.

K number K930282

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IZH 1993-02-26

CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR

Applicant Bennett X-Ray Corp.

K number K925725

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IZH 1993-01-15

GIOTTO PATIENT BED

Applicant Gold Coast Imaging, Inc.

K number K925212

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IZH 1992-11-24

PLANMED CYTOGUIDE

Applicant Planmed OY

K number K923471

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IZH 1992-11-23

LORAD DIGITAL SPOT MAMMOGRAPHY

Applicant Lorad Medical Systems, Inc.

K number K921962

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IZH 1992-10-16

PATIENT INFORMATION MANAGER (PIM)

Applicant Continental X-Ray Corp.

K number K921986

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IZH 1992-09-11

MOBILE ATHENA HF

Applicant Fischer Imaging Corp.

K number K922454

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IZH 1992-09-10

MAMMOSCAN

Applicant Fischer Imaging Corp.

K number K923061

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IZH 1992-08-26

MEYER FOREIGN BODY LOCATOR

Applicant Seymour W. Meyer

K number K920470

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IZH 1992-08-03

TILTING MAG

Applicant Continental X-Ray Corp.

K number K921896

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IZH 1992-07-28

CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO

Applicant Bennett X-Ray Corp.

K number K915201

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IZH 1992-07-01

DIGITIZER, MODEL # 3-000A-1518

Applicant Lorad Medical Systems, Inc.

K number K922619

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IZH 1992-06-17

VJW2919 PNEUMATIC COMPRESSION UPGRADE

Applicant Varian Canada, Inc.

K number K920938

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IZH 1992-02-04

AVIVA MAMMOGRAPHIC X-RAY SYSTEM

Applicant Elscint, Inc.

K number K915748

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IZH 1992-02-03

MAMMOGRAPHIC X-RAY SYSTEM

Applicant Lorad Medical Systems, Inc.

K number K913732

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IZH 1992-01-06

SENOGRAPHE DMR/SMR/DM

Applicant General Electric Co.

K number K913418

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IZH 1991-12-20

PHILIPS MAMMODIAGNOST BC

Applicant Philips Medical Systems, Inc.

K number K913845

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IZH 1991-12-02

MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K914328

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IZH 1991-09-23

VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS

Applicant Instrumentarium Imaging, Inc.

K number K910111

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IZH 1991-09-19

MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM

Applicant Elscint, Inc.

K number K912974

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IZH 1991-05-30

ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL

Applicant Instrumentarium Imaging, Inc.

K number K896596

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IZH 1991-04-18

PLANMED SOPHIE

Applicant Planmeca USA, Inc.

K number K904953

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IZH 1991-03-07

MAMEX DC AMI SL12/MG15

Applicant Soredex, Inc.

K number K905748

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IZH 1990-11-15

MAMMOSPOT 3 AND MAMMOSPOT 8

Applicant American Mammographics, Inc.

K number K904517

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IZH 1990-11-15

AMI MAMMOSPOT

Applicant American Mammographics, Inc.

K number K903651

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IZH 1990-07-03

GIOTTO MAMMOGRAPHY HF

Applicant Medical Device Marketing Network, Inc.

K number K901558

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IZH 1990-06-06

X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS

Applicant Comet Ltd. C/O Radiology Resources, Inc.

K number K901997

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IZH 1990-03-28

ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM

Applicant Fischer Imaging Corp.

K number K900989

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IZH 1990-01-31

CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC

Applicant Philips Medical Systems North America, Inc.

K number K896609

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IZH 1989-11-17

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

Applicant Bay Shore Medical Equipment Corp.

K number K892342

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IZH 1989-05-05

STEREOTACTIC BIOPSY ATTACHMENT

Applicant Siemens Medical Solutions USA, Inc.

K number K884107

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IZH 1989-05-03

MAMMOMAT C

Applicant Siemens Medical Solutions USA, Inc.

K number K890784

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IZH 1989-04-26

CYTOGUIDE

Applicant Philips Medical Systems North America, Inc.

K number K885020

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IZH 1989-04-07

SPECBOARD

Applicant Macbrud Corp. Medical Div.

K number K891090

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IZH 1989-03-23

MODEL ESP-200 MAMMOGRAPHIC SYSTEM

Applicant Acoma Medical Imaging, Inc.

K number K884345

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IZH 1989-03-14

THE PATHFINDER SYSTEM

Applicant Denmark Assoc.

K number K890483

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IZH 1989-03-09

MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150

Applicant Bennett X-Ray Corp.

K number K885135

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IZH 1989-03-09

RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM

Applicant Amg Medical Equipments, Inc.

K number K884917

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IZH 1989-01-06

MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.

Applicant Elscint, Inc.

K number K884677

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IZH 1989-01-06

MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.

Applicant Elscint, Inc.

K number K884676

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IZH 1988-11-07

STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY

Applicant Lorad Medical Systems, Inc.

K number K882875

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IZH 1988-09-19

MAMMO M

Applicant Ziehm International, Inc.

K number K882133

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IZH 1988-09-14

BREAST LESION LOCALIZATION NEEDLE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K881697

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IZH 1988-06-10

MAMEX DC MAG MG12

Applicant Orion Corp.

K number K881506

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IZH 1988-06-10

MAMEX DC MG11

Applicant Orion Corp.

K number K881505

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IZH 1988-05-25

SENOGRAPHE 600T AND 600TS SENIX HF

Applicant General Electric Co.

K number K881882

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IZH 1988-05-02

MAMMOGRAPHIC X-RAY SYSTEM ATHENA

Applicant Fischer Imaging Corp.

K number K880531

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IZH 1988-03-21

MAMMOGRAPHY MOVING GRID BUCKY

Applicant Custom Medical Products, Ltd.

K number K880905

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IZH 1988-02-12

SHIMADZU MAMMOGRAPHIC STAND MR-30

Applicant Shimadzu Precision Instruments, Inc.

K number K875377

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IZH 1987-11-23

MAMEX DC S SL10/MG14

Applicant Orion Corp.

K number K874040

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IZH 1987-11-16

STEREOTIX

Applicant Thomson-Cgr Medical Corp.

K number K873618

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IZH 1987-10-16

MAMMOGRAPHIC KVP METER MODEL 232

Applicant Radiation Measurements, Inc.

K number K873836

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IZH 1987-10-08

MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE

Applicant Palomex Instrumentarium Corp.

K number K872734

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IZH 1987-09-01

MICRO MAMMO I MAMMOGRAPHY UNIT

Applicant Amerasia Import-Export, Inc.

K number K871048

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IZH 1987-08-27

MAM-CP X-RAY APPARATUS

Applicant Transworld X-Ray Corp.

K number K872980

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IZH 1987-05-22

RF-1 CIRCUIT

Applicant Diagnostic Imaging Specialists Corp.

K number K871592

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IZH 1987-01-30

ALPHA II DIAGNOSTIC X-RAY

Applicant Ausonics Pty , Ltd.

K number K864958

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IZH 1986-12-15

FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM

Applicant Fischer Imaging Corp.

K number K861692

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IZH 1986-10-14

ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

Applicant Ausonics Pty , Ltd.

K number K863710

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IZH 1986-03-06

ISO-MAMMO

Applicant Philips Medical Systems (Cleveland), Inc.

K number K860129

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IZH 1986-03-06

TEC 2720 MAMEX DC MAG

Applicant Tecnomed, Inc.

K number K854203

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IZH 1986-01-01

MINXRAY 500M MAMMOGRAPHIC SYSTEM

Applicant Minxray, Inc.

K number K854510

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IZH 1985-11-01

RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000

Applicant Raytheon Medical Systems

K number K853395

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IZH 1985-07-19

MAMMOGRAPH III

Applicant American Medical Imports, Inc.

K number K844119

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IZH 1985-04-16

AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT

Applicant Ausonics Pty , Ltd.

K number K850173

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IZH 1985-03-26

SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY

Applicant S & S X-Ray Products, Inc.

K number K850614

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IZH 1984-11-27

MEI MAMMOGRAPHY SYS MX-2049

Applicant Moti Enterprises, Inc.

K number K843437

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IZH 1984-07-17

LORAD

Applicant Lorad Medical Systems, Inc.

K number K842102

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IZH 1984-06-26

UNIMACS, PATENT PENDING UNIVERSAL MAM

Applicant Technical Devices For Medicine

K number K841774

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IZH 1983-10-28

MAMMOGRAPHIC S-RAY SYSTEM

Applicant Xerox Medical Systems

K number K833243

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IZH 1983-09-29

XEROX 120 SYS MAMMOGRAPHIC X-RAY

Applicant Xerox Medical Systems

K number K832733

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IZH 1979-03-21

MAMMOGRAPHY SYSTEM AND CASSETTE

Applicant Agfa-Gevaert, Inc.

K number K790273

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IZH 1977-08-03

X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC

Applicant Xonics Medical Systems, Inc.

K number K770693

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