Atlas FDA

IZH

176 FDA 510(k) clearances · Product code

77 daysmedian time to decision
227 days90th percentile
176clearances measured

FDA profile

Official device name
System, X-Ray, Mammographic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1710
Medical specialty
Radiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 8 · 2016: 9 · 2017: 12 · 2018: 25 · 2019: 39 · 2026: 21
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
SMART FINDER (K203509)Ims Giotto S.P.A.2021-07-14
Affirm Contrast Biopsy (K202294)Hologic, Inc.2020-10-05
Biopsy Positioner (K191495)Fujifilm Corporation2019-07-03
Affirm Lateral Arm Upright Biopsy Accessory (K161575)Hologic2016-08-10
Comfort Cover (K161920)Precision Dynamics Corporation2016-07-15
Affirm Prone Biopsy System (K153486)Hologic, Inc.2016-04-01
MammoGRIP (K152038)Women'S Imaging Solutions Enterprises, LLC2015-12-22
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K122836)Lorad, A Hologic Co.2013-01-11
SPECBOARD JR. (K123414)Macbrud Corp., Medical Division2013-01-11
BIOPSY DIGIT S BIOPSY SL (K113607)Giotto USA, LLC2012-08-10
BIOPSY POSITIONER (K113284)Fuji Film Medical Systems2012-03-07
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM (K103512)Hologic, Inc.2011-01-07
EMBRACE (K101373)Izi Medical Products, Inc.2010-09-15
DIGITAL SPOT MAMMOGRAPHY SYSTEM (K100692)Hologic, Inc.2010-04-06
BELLA (K073262)Beekley Corp.2008-03-26
BEMITT, MODEL 0001 (K071787)Dja Distributors, LLC2007-10-26
DIGITAL STEREOLOC II (K071542)Lorad, A Hologic Co.2007-07-05
LIV BREAST SELF EXAMINATION AID (K070344)Liv International USA, Inc.2007-03-08
BIOPSY DIGIT-AM (K062039)Giotto USA, LLC2006-09-11
TRAXYLOC-1 SYSTEM (K050663)Traxyz Medical, Inc.2005-04-08
PLANMED SOPHIE NUANCE CLASSIC (K042671)Planmed OY2004-11-19
MAMMOTEST (K042095)Fischer Imaging Corp.2004-10-29
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM (K040884)Hologic, Inc.2004-04-23
SENOGRAPHIC STEREO (K040125)Ge Medical Systems, Inc.2004-04-19
ADVANTAGE PADDLE (K033202)Livingston Products, Inc.2003-12-03
SQUEEZE-EASE MAMMOGRAPHY CUSHION (K031574)S & S X-Ray Products, Inc.2003-08-04
MULTICARE PLATINUM SYSTEM AND ACCESSORIES (K030666)Lorad, A Hologic Co.2003-03-25
PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE) (K021945)Planmed OY2003-02-21
PERFORMA STEREO (K023864)Instrumentarium Corp. Imaging Division2003-01-09
S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE (K023229)American Mammographics, Inc.2002-12-13
BREAST BOLSTER (K020624)Beekley Corp.2002-09-12
DELTA 32; DELTA 32 TACT (K022275)Instrumentarium Corp. Imaging Division2002-09-12
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC (K013656)Planmed OY2002-01-16
GIOTTO IMAGE (K012953)Medx, Inc.2001-11-30
MODIFIED 650 MAMMOGRAPHY SYSTEM (K013290)Lorad, A Hologic Co.2001-10-24
MODIFIED M-IV MAMMOGRAPHY SYSTEM (K011987)Lorad, A Hologic Co.2001-07-11
MAMMOGRAPH (K010792)Digitec Medical Service Corp.2001-04-03
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC (K010116)Planmed OY2001-03-15
BIOLUCENT MAMMOGRAPHY CUSHION (K003795)Biolucent, Inc.2001-02-14
OPDIMA (K003945)Siemens Medical Solutions USA, Inc.2001-02-02
DELTA 32 AND DELTA 32 TACT (K002472)Instrumentarium Imaging, Inc.2000-11-29
DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM (K003473)Elscintec Systems , Ltd.2000-11-28
DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM) (K000976)Instrumentarium Imaging, Inc.2000-06-01
DELTA 16 TACT (K001171)Instrumentarium Imaging, Inc.2000-05-12
DIGITEC TWO STAGE COMPRESSION KIT (K993681)Digitec Medical Service Corp.1999-12-21
MAMEX (K993740)Medical Systems Group1999-11-26
LORAD 1-650 (INTERNATIONAL 650) (K992280)Lorad Corp.1999-09-03
PLANMED SOPHIE AND SOPHIE CLASSIC (K991826)Planmed OY1999-08-10
MAMEX (K992037)Del Medical Imaging Corp.1999-07-30
BIOPSY-DIGIT (K990192)Sitco, Inc.1999-03-12
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000 (K984091)Trex Medical Corp.1999-02-05
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000 (K984092)Trex Medical Corp.1999-02-05
ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY (K983313)Elscint, Inc.1998-12-11
PLANMED SOPHIE & PLANNED SOPHIE CLASSIC (K983659)Planmed OY1998-11-16
NEEDLE GUIDE (K983621)Remington Medical, Inc.1998-11-03
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ (K981641)Instrumentarium Corp.1998-07-17
BIOPSY M (K982049)Sitco, Inc.1998-07-14
WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE (K981470)Worldwide Medical Technologies, LLC1998-06-19
REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR) (K980235)Kci New Technologies, Inc.1998-04-09
LORAD M-III ELITE (M-III E) (K973631)Lorad Corp.1997-12-23
GIOTTO HT (K973856)Sitco, Inc.1997-11-21
PLANMED CYTOGUIDE (K973493)Planmed OY1997-11-10
MAMMOTEST ADAPTER DRIVER (K973400)Fischer Imaging Corp.1997-11-10
INFLATABLE POSITIONING CUSHIONS (K973915)Kci New Technologies, Inc.1997-11-10
GLORY (K970680)Elscint, Inc.1997-06-20
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM (K964069)Siemens Medical Solutions USA, Inc.1997-05-08
GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM (K953902)Medical Marketing Intl., Inc.1997-03-19
PLANNED SOPHIED CLASSIC (K962105)Planmed OY1997-02-05
PROFILE MAMMOGRAPHY SYSTEM (M-PRO) (K964576)Bennett X-Ray Corp.1997-01-10
THE ROBOGUIDE (K961849)Shai Syg Motion and Innovations, Ltd.1996-08-21
MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION (K960381)Elscint, Inc.1996-04-29
DELTA 16 (K955411)Instrumentarium Imaging, Inc.1996-03-21
SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE (K953250)GE Medical Systems1996-01-26
SENSOR PAD (K955249)Inventive Products, Inc.1995-12-22
MAMMOSPOT PADDLE (K954521)American Mammographics, Inc.1995-10-24
LORAD STEROLOC II (K952210)Lorad Corp.1995-07-24
PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT (K951883)Planmed OY1995-05-24
REAL TIME STEREOTIX (K941191)GE Medical Systems1995-05-11
BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI (K944978)Bennett X-Ray Corp.1995-05-03
BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY (K945962)Bennett X-Ray Corp.1995-04-03
MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM (K941353)Elscint, Inc.1995-03-31
LORAD M-IV, LORAD M-IVI (K945241)Lorad Corp.1995-03-31
PREFERENCE MAMMOGRAPHY SYSTEM (K945743)Philips Medical Systems (Cleveland), Inc.1995-03-31
ATHENA HFX (K945619)Fischer Imaging Corp.1995-03-23
DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION (K950608)Lorad Corp.1995-03-02
SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) (K944816)Philips Medical Systems (Cleveland), Inc.1995-02-08
NOVA XM2 (K932356)Dynarad Corp.1995-02-08
ALPHA STEREO (K934478)Instrumentarium Corp.1995-01-31
MAMMOGRAPHIC X-RAY UNIT (K945496)Lorad Corp.1994-12-27
RHODIUM FILTER (K945272)Lorad Corp.1994-12-14
BENNETT X-RAY DIGITAL SPOT IMAGER (K935428)Bennett X-Ray Technologies1994-11-01
LORAD TRANSPO (K934868)Lorad Corp.1994-10-14
CYTOGUIDE STEREOTATIC BIOPSY SYSTEM (K933430)Gold Coast Imaging, Inc.1994-09-22
MAMMOMAT 300 AND MAMMOMAT 3000 (K932672)Siemens Medical Solutions USA, Inc.1994-09-14
ADVANCED AUTOMATIC KV (K934831)Elscint, Inc.1994-08-23
MAMOSPAT (K935608)E.V.S. Tool & Die Co., Inc.1994-05-17
SYSTEM, X-RAY, MAMOGRAPHIC (K936161)Technowipe1994-05-04
BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH (K940701)Bennett X-Ray Corp.1994-04-28
MOBILE SOPHIE MODIFICATION (K934373)Planmed OY1994-04-07
LORAD D-550 (K934870)Lorad Corp.1994-01-31
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