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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 2021-07-14

SMART FINDER

Applicant Ims Giotto S.P.A.

K number K203509

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IZH 2020-10-05

Affirm Contrast Biopsy

Applicant Hologic, Inc.

K number K202294

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IZH 2019-07-03

Biopsy Positioner

Applicant Fujifilm Corporation

K number K191495

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IZH 2016-08-10

Affirm Lateral Arm Upright Biopsy Accessory

Applicant Hologic

K number K161575

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IZH 2016-07-15

Comfort Cover

Applicant Precision Dynamics Corporation

K number K161920

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IZH 2016-04-01

Affirm Prone Biopsy System

Applicant Hologic, Inc.

K number K153486

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IZH 2013-01-11

SPECBOARD JR.

Applicant Macbrud Corp., Medical Division

K number K123414

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IZH 2013-01-11

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Applicant Lorad, A Hologic Co.

K number K122836

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IZH 2012-08-10

BIOPSY DIGIT S BIOPSY SL

Applicant Giotto USA, LLC

K number K113607

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IZH 2012-03-07

BIOPSY POSITIONER

Applicant Fuji Film Medical Systems

K number K113284

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IZH 2011-01-07

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

Applicant Hologic, Inc.

K number K103512

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IZH 2010-09-15

EMBRACE

Applicant Izi Medical Products, Inc.

K number K101373

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IZH 2010-04-06

DIGITAL SPOT MAMMOGRAPHY SYSTEM

Applicant Hologic, Inc.

K number K100692

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IZH 2008-03-26

BELLA

Applicant Beekley Corp.

K number K073262

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IZH 2007-10-26

BEMITT, MODEL 0001

Applicant Dja Distributors, LLC

K number K071787

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IZH 2007-07-05

DIGITAL STEREOLOC II

Applicant Lorad, A Hologic Co.

K number K071542

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IZH 2007-03-08

LIV BREAST SELF EXAMINATION AID

Applicant Liv International USA, Inc.

K number K070344

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IZH 2006-09-11

BIOPSY DIGIT-AM

Applicant Giotto USA, LLC

K number K062039

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IZH 2005-04-08

TRAXYLOC-1 SYSTEM

Applicant Traxyz Medical, Inc.

K number K050663

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IZH 2004-11-19

PLANMED SOPHIE NUANCE CLASSIC

Applicant Planmed OY

K number K042671

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IZH 2004-10-29

MAMMOTEST

Applicant Fischer Imaging Corp.

K number K042095

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IZH 2004-04-23

LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM

Applicant Hologic, Inc.

K number K040884

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IZH 2004-04-19

SENOGRAPHIC STEREO

Applicant Ge Medical Systems, Inc.

K number K040125

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IZH 2003-12-03

ADVANTAGE PADDLE

Applicant Livingston Products, Inc.

K number K033202

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IZH 2003-08-04

SQUEEZE-EASE MAMMOGRAPHY CUSHION

Applicant S & S X-Ray Products, Inc.

K number K031574

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IZH 2003-03-25

MULTICARE PLATINUM SYSTEM AND ACCESSORIES

Applicant Lorad, A Hologic Co.

K number K030666

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IZH 2003-02-21

PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)

Applicant Planmed OY

K number K021945

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IZH 2003-01-09

PERFORMA STEREO

Applicant Instrumentarium Corp. Imaging Division

K number K023864

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IZH 2002-12-13

S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE

Applicant American Mammographics, Inc.

K number K023229

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IZH 2002-09-12

DELTA 32; DELTA 32 TACT

Applicant Instrumentarium Corp. Imaging Division

K number K022275

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IZH 2002-09-12

BREAST BOLSTER

Applicant Beekley Corp.

K number K020624

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IZH 2002-01-16

PLANMED SOPHIE & PLANMED SOPHIE CLASSIC

Applicant Planmed OY

K number K013656

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IZH 2001-11-30

GIOTTO IMAGE

Applicant Medx, Inc.

K number K012953

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IZH 2001-10-24

MODIFIED 650 MAMMOGRAPHY SYSTEM

Applicant Lorad, A Hologic Co.

K number K013290

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IZH 2001-07-11

MODIFIED M-IV MAMMOGRAPHY SYSTEM

Applicant Lorad, A Hologic Co.

K number K011987

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IZH 2001-04-03

MAMMOGRAPH

Applicant Digitec Medical Service Corp.

K number K010792

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IZH 2001-03-15

PLANMED SOPHIE, PLANMED SOPHIE CLASSIC

Applicant Planmed OY

K number K010116

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IZH 2001-02-14

BIOLUCENT MAMMOGRAPHY CUSHION

Applicant Biolucent, Inc.

K number K003795

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IZH 2001-02-02

OPDIMA

Applicant Siemens Medical Solutions USA, Inc.

K number K003945

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IZH 2000-11-29

DELTA 32 AND DELTA 32 TACT

Applicant Instrumentarium Imaging, Inc.

K number K002472

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IZH 2000-11-28

DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM

Applicant Elscintec Systems , Ltd.

K number K003473

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IZH 2000-06-01

DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)

Applicant Instrumentarium Imaging, Inc.

K number K000976

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IZH 2000-05-12

DELTA 16 TACT

Applicant Instrumentarium Imaging, Inc.

K number K001171

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IZH 1999-12-21

DIGITEC TWO STAGE COMPRESSION KIT

Applicant Digitec Medical Service Corp.

K number K993681

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IZH 1999-11-26

MAMEX

Applicant Medical Systems Group

K number K993740

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IZH 1999-09-03

LORAD 1-650 (INTERNATIONAL 650)

Applicant Lorad Corp.

K number K992280

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IZH 1999-08-10

PLANMED SOPHIE AND SOPHIE CLASSIC

Applicant Planmed OY

K number K991826

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IZH 1999-07-30

MAMEX

Applicant Del Medical Imaging Corp.

K number K992037

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IZH 1999-03-12

BIOPSY-DIGIT

Applicant Sitco, Inc.

K number K990192

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IZH 1999-02-05

PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000

Applicant Trex Medical Corp.

K number K984092

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IZH 1999-02-05

CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000

Applicant Trex Medical Corp.

K number K984091

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IZH 1998-12-11

ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY

Applicant Elscint, Inc.

K number K983313

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IZH 1998-11-16

PLANMED SOPHIE & PLANNED SOPHIE CLASSIC

Applicant Planmed OY

K number K983659

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IZH 1998-11-03

NEEDLE GUIDE

Applicant Remington Medical, Inc.

K number K983621

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IZH 1998-07-17

MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ

Applicant Instrumentarium Corp.

K number K981641

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IZH 1998-07-14

BIOPSY M

Applicant Sitco, Inc.

K number K982049

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IZH 1998-06-19

WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE

Applicant Worldwide Medical Technologies, LLC

K number K981470

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IZH 1998-04-09

REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)

Applicant Kci New Technologies, Inc.

K number K980235

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IZH 1997-12-23

LORAD M-III ELITE (M-III E)

Applicant Lorad Corp.

K number K973631

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IZH 1997-11-21

GIOTTO HT

Applicant Sitco, Inc.

K number K973856

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IZH 1997-11-10

INFLATABLE POSITIONING CUSHIONS

Applicant Kci New Technologies, Inc.

K number K973915

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IZH 1997-11-10

PLANMED CYTOGUIDE

Applicant Planmed OY

K number K973493

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IZH 1997-11-10

MAMMOTEST ADAPTER DRIVER

Applicant Fischer Imaging Corp.

K number K973400

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IZH 1997-06-20

GLORY

Applicant Elscint, Inc.

K number K970680

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IZH 1997-05-08

DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM

Applicant Siemens Medical Solutions USA, Inc.

K number K964069

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IZH 1997-03-19

GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM

Applicant Medical Marketing Intl., Inc.

K number K953902

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IZH 1997-02-05

PLANNED SOPHIED CLASSIC

Applicant Planmed OY

K number K962105

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IZH 1997-01-10

PROFILE MAMMOGRAPHY SYSTEM (M-PRO)

Applicant Bennett X-Ray Corp.

K number K964576

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IZH 1996-08-21

THE ROBOGUIDE

Applicant Shai Syg Motion and Innovations, Ltd.

K number K961849

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IZH 1996-04-29

MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION

Applicant Elscint, Inc.

K number K960381

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IZH 1996-03-21

DELTA 16

Applicant Instrumentarium Imaging, Inc.

K number K955411

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IZH 1996-01-26

SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE

Applicant GE Medical Systems

K number K953250

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IZH 1995-12-22

SENSOR PAD

Applicant Inventive Products, Inc.

K number K955249

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IZH 1995-10-24

MAMMOSPOT PADDLE

Applicant American Mammographics, Inc.

K number K954521

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IZH 1995-07-24

LORAD STEROLOC II

Applicant Lorad Corp.

K number K952210

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IZH 1995-05-24

PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT

Applicant Planmed OY

K number K951883

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IZH 1995-05-11

REAL TIME STEREOTIX

Applicant GE Medical Systems

K number K941191

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IZH 1995-05-03

BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI

Applicant Bennett X-Ray Corp.

K number K944978

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IZH 1995-04-03

BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY

Applicant Bennett X-Ray Corp.

K number K945962

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IZH 1995-03-31

PREFERENCE MAMMOGRAPHY SYSTEM

Applicant Philips Medical Systems (Cleveland), Inc.

K number K945743

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IZH 1995-03-31

LORAD M-IV, LORAD M-IVI

Applicant Lorad Corp.

K number K945241

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IZH 1995-03-31

MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM

Applicant Elscint, Inc.

K number K941353

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IZH 1995-03-23

ATHENA HFX

Applicant Fischer Imaging Corp.

K number K945619

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IZH 1995-03-02

DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION

Applicant Lorad Corp.

K number K950608

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IZH 1995-02-08

SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)

Applicant Philips Medical Systems (Cleveland), Inc.

K number K944816

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IZH 1995-02-08

NOVA XM2

Applicant Dynarad Corp.

K number K932356

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IZH 1995-01-31

ALPHA STEREO

Applicant Instrumentarium Corp.

K number K934478

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IZH 1994-12-27

MAMMOGRAPHIC X-RAY UNIT

Applicant Lorad Corp.

K number K945496

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IZH 1994-12-14

RHODIUM FILTER

Applicant Lorad Corp.

K number K945272

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IZH 1994-11-01

BENNETT X-RAY DIGITAL SPOT IMAGER

Applicant Bennett X-Ray Technologies

K number K935428

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IZH 1994-10-14

LORAD TRANSPO

Applicant Lorad Corp.

K number K934868

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IZH 1994-09-22

CYTOGUIDE STEREOTATIC BIOPSY SYSTEM

Applicant Gold Coast Imaging, Inc.

K number K933430

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IZH 1994-09-14

MAMMOMAT 300 AND MAMMOMAT 3000

Applicant Siemens Medical Solutions USA, Inc.

K number K932672

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IZH 1994-08-23

ADVANCED AUTOMATIC KV

Applicant Elscint, Inc.

K number K934831

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IZH 1994-05-17

MAMOSPAT

Applicant E.V.S. Tool & Die Co., Inc.

K number K935608

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IZH 1994-05-04

SYSTEM, X-RAY, MAMOGRAPHIC

Applicant Technowipe

K number K936161

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IZH 1994-04-28

BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH

Applicant Bennett X-Ray Corp.

K number K940701

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IZH 1994-04-07

MOBILE SOPHIE MODIFICATION

Applicant Planmed OY

K number K934373

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IZH 1994-01-31

LORAD D-550

Applicant Lorad Corp.

K number K934870

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IZH 1994-01-31

LORAD M-IIE MODIFICATION

Applicant Lorad Corp.

K number K934748

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