Product Code: IZH FDA class 2 21 CFR 892.1710

System, X-Ray, Mammographic

Radiology

A mammographic X-ray system is specifically designed for imaging breast tissue at low radiation doses, used for the detection and diagnosis of breast cancer and other abnormalities. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before it can be marketed. The product code is IZH, regulated under 21 CFR 892.1710, within the Radiology medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

176

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: IZH
Device Class: FDA class 2
Regulation Number: 892.1710
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 176 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203509	SMART FINDER	Jul 14, 2021	Substantially Equivalent	IMS Giotto S.p.A.
K202294	Affirm Contrast Biopsy	Oct 05, 2020	Substantially Equivalent	Hologic, Inc
K191495	Biopsy Positioner	Jul 03, 2019	Substantially Equivalent	FUJIFILM Corporation
K161575	Affirm Lateral Arm Upright Biopsy Accessory	Aug 10, 2016	Substantially Equivalent	HOLOGIC
K161920	Comfort Cover	Jul 15, 2016	Substantially Equivalent	PRECISION DYNAMICS CORPORATION
K153486	Affirm Prone Biopsy System	Apr 01, 2016	Substantially Equivalent	Hologic Inc
K152038	MammoGRIP	Dec 22, 2015	Substantially Equivalent	Women's Imaging Solutions Enterprises LLC
K123414	SPECBOARD JR.	Jan 11, 2013	Substantially Equivalent	MACBRUD CORP., MEDICAL DIVISION
K122836	AFFIRM BREAST BIOPSY GUIDANCE SYSTEM	Jan 11, 2013	Substantially Equivalent	LORAD, A HOLOGIC CO.
K113607	BIOPSY DIGIT S BIOPSY SL	Aug 10, 2012	Substantially Equivalent	GIOTTO USA, LLC
K113284	BIOPSY POSITIONER	Mar 07, 2012	Substantially Equivalent	FUJI FILM MEDICAL SYSTEMS
K103512	AFFIRM BREAST BIOPSY GUIDANCE SYSTEM	Jan 07, 2011	Substantially Equivalent	HOLOGIC, INC.
K101373	EMBRACE	Sep 15, 2010	Substantially Equivalent	IZI MEDICAL PRODUCTS INC.
K100692	DIGITAL SPOT MAMMOGRAPHY SYSTEM	Apr 06, 2010	Substantially Equivalent	HOLOGIC, INC.
K073262	BELLA	Mar 26, 2008	Substantially Equivalent	BEEKLEY CORP.
K071787	BEMITT, MODEL 0001	Oct 26, 2007	Substantially Equivalent	DJA DISTRIBUTORS, LLC
K071542	DIGITAL STEREOLOC II	Jul 05, 2007	Substantially Equivalent	LORAD, A HOLOGIC CO.
K070344	LIV BREAST SELF EXAMINATION AID	Mar 08, 2007	Substantially Equivalent	LIV INTERNATIONAL USA, INC.
K062039	BIOPSY DIGIT-AM	Sep 11, 2006	Substantially Equivalent	GIOTTO USA, LLC
K050663	TRAXYLOC-1 SYSTEM	Apr 08, 2005	Substantially Equivalent	TRAXYZ MEDICAL, INC.
K042671	PLANMED SOPHIE NUANCE CLASSIC	Nov 19, 2004	Substantially Equivalent	PLANMED OY
K042095	MAMMOTEST	Oct 29, 2004	Substantially Equivalent	FISCHER IMAGING CORP.
K040884	LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM	Apr 23, 2004	Substantially Equivalent	HOLOGIC, INC.
K040125	SENOGRAPHIC STEREO	Apr 19, 2004	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K033202	ADVANTAGE PADDLE	Dec 03, 2003	Substantially Equivalent	LIVINGSTON PRODUCTS, INC.
K031574	SQUEEZE-EASE MAMMOGRAPHY CUSHION	Aug 04, 2003	Substantially Equivalent	S & S X-RAY PRODUCTS, INC.
K030666	MULTICARE PLATINUM SYSTEM AND ACCESSORIES	Mar 25, 2003	Substantially Equivalent	LORAD, A HOLOGIC CO.
K021945	PLANMED SOPHIE & SOPHIE CLASSIC (WITH DIGISPOT AND CYTOGUIDE)	Feb 21, 2003	Substantially Equivalent	PLANMED OY
K023864	PERFORMA STEREO	Jan 09, 2003	Substantially Equivalent	INSTRUMENTARIUM CORP. IMAGING DIVISION
K023229	S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE	Dec 13, 2002	Substantially Equivalent	AMERICAN MAMMOGRAPHICS, INC.
K022275	DELTA 32; DELTA 32 TACT	Sep 12, 2002	Substantially Equivalent	INSTRUMENTARIUM CORP. IMAGING DIVISION
K020624	BREAST BOLSTER	Sep 12, 2002	Substantially Equivalent	BEEKLEY CORP.
K013656	PLANMED SOPHIE & PLANMED SOPHIE CLASSIC	Jan 16, 2002	Substantially Equivalent	PLANMED OY
K012953	GIOTTO IMAGE	Nov 30, 2001	Substantially Equivalent	MEDX, INC.
K013290	MODIFIED 650 MAMMOGRAPHY SYSTEM	Oct 24, 2001	Substantially Equivalent	LORAD, A HOLOGIC CO.
K011987	MODIFIED M-IV MAMMOGRAPHY SYSTEM	Jul 11, 2001	Substantially Equivalent	LORAD, A HOLOGIC CO.
K010792	MAMMOGRAPH	Apr 03, 2001	Substantially Equivalent	DIGITEC MEDICAL SERVICE CORP.
K010116	PLANMED SOPHIE, PLANMED SOPHIE CLASSIC	Mar 15, 2001	Substantially Equivalent	PLANMED OY
K003795	BIOLUCENT MAMMOGRAPHY CUSHION	Feb 14, 2001	Substantially Equivalent	BIOLUCENT, INC.
K003945	OPDIMA	Feb 02, 2001	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K002472	DELTA 32 AND DELTA 32 TACT	Nov 29, 2000	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K003473	DIGIMAM DIGITAL STEREOTACTIC BIOPSY SYSTEM OPTION FOR GLORY MAMMOGRAPHIC SYSTEM	Nov 28, 2000	Substantially Equivalent	ELSCINTEC SYSTEMS LTD.
K000976	DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)	Jun 01, 2000	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K001171	DELTA 16 TACT	May 12, 2000	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K993681	DIGITEC TWO STAGE COMPRESSION KIT	Dec 21, 1999	Substantially Equivalent	DIGITEC MEDICAL SERVICE CORP.
K993740	MAMEX	Nov 26, 1999	Substantially Equivalent	MEDICAL SYSTEMS GROUP
K992280	LORAD 1-650 (INTERNATIONAL 650)	Sep 03, 1999	Substantially Equivalent	LORAD CORP.
K991826	PLANMED SOPHIE AND SOPHIE CLASSIC	Aug 10, 1999	Substantially Equivalent	PLANMED OY
K992037	MAMEX	Jul 30, 1999	Substantially Equivalent	DEL MEDICAL IMAGING CORP.
K990192	BIOPSY-DIGIT	Mar 12, 1999	Substantially Equivalent	SITCO, INC.
K984092	PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000	Feb 05, 1999	Substantially Equivalent	TREX MEDICAL CORP.
K984091	CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000	Feb 05, 1999	Substantially Equivalent	TREX MEDICAL CORP.
K983313	ADVANCED AUTOMATIC DETECTOR SELECTION OPTION FOR GLORY	Dec 11, 1998	Substantially Equivalent	ELSCINT, INC.
K983659	PLANMED SOPHIE & PLANNED SOPHIE CLASSIC	Nov 16, 1998	Substantially Equivalent	PLANMED OY
K983621	NEEDLE GUIDE	Nov 03, 1998	Substantially Equivalent	REMINGTON MEDICAL, INC.
K981641	MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ	Jul 17, 1998	Substantially Equivalent	INSTRUMENTARIUM CORP.
K982049	BIOPSY M	Jul 14, 1998	Substantially Equivalent	SITCO, INC.
K981470	WORLDWIDE MEDICAL TECHNOLOGIES NEEDLE GUIDE	Jun 19, 1998	Substantially Equivalent	WORLDWIDE MEDICAL TECHNOLOGIES, LLC
K980235	REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)	Apr 09, 1998	Substantially Equivalent	KCI NEW TECHNOLOGIES, INC.
K973631	LORAD M-III ELITE (M-III E)	Dec 23, 1997	Substantially Equivalent	LORAD CORP.
K973856	GIOTTO HT	Nov 21, 1997	Substantially Equivalent	SITCO, INC.
K973915	INFLATABLE POSITIONING CUSHIONS	Nov 10, 1997	Substantially Equivalent	KCI NEW TECHNOLOGIES, INC.
K973493	PLANMED CYTOGUIDE	Nov 10, 1997	Substantially Equivalent	PLANMED OY
K973400	MAMMOTEST ADAPTER DRIVER	Nov 10, 1997	Substantially Equivalent	FISCHER IMAGING CORP.
K970680	GLORY	Jun 20, 1997	Substantially Equivalent	ELSCINT, INC.
K964069	DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM	May 08, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K953902	GIOTTO HIGH TECH (H.T.) MAMMOGRAPHIC SYSTEM	Mar 19, 1997	Substantially Equivalent	MEDICAL MARKETING INTL., INC.
K962105	PLANNED SOPHIED CLASSIC	Feb 05, 1997	Substantially Equivalent	PLANMED OY
K964576	PROFILE MAMMOGRAPHY SYSTEM (M-PRO)	Jan 10, 1997	Substantially Equivalent	BENNETT X-RAY CORP.
K961849	THE ROBOGUIDE	Aug 21, 1996	Substantially Equivalent	SHAI SYG MOTION AND INNOVATIONS, LTD.
K960381	MAM-CH22S WITH AUTOMATIC FILTER SELECTION OPTION	Apr 29, 1996	Substantially Equivalent	ELSCINT, INC.
K955411	DELTA 16	Mar 21, 1996	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K953250	SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE	Jan 26, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K955249	SENSOR PAD	Dec 22, 1995	Substantially Equivalent	INVENTIVE PRODUCTS, INC.
K954521	MAMMOSPOT PADDLE	Oct 24, 1995	Substantially Equivalent	AMERICAN MAMMOGRAPHICS, INC.
K952210	LORAD STEROLOC II	Jul 24, 1995	Substantially Equivalent	LORAD CORP.
K951883	PLANMED SOPHIE MAMMOGRAPHIC X-RAY UNIT	May 24, 1995	Substantially Equivalent	PLANMED OY
K941191	REAL TIME STEREOTIX	May 11, 1995	Substantially Equivalent	GE MEDICAL SYSTEMS
K944978	BENNETT X-RAY DIGITAL SPOT IMAGING SYSTEM MODEL M-DSI	May 03, 1995	Substantially Equivalent	BENNETT X-RAY CORP.
K945962	BENNETT X-RAY PROFILE POSITIONING PADDLE FOR MAMMOGRAPHY	Apr 03, 1995	Substantially Equivalent	BENNETT X-RAY CORP.
K945743	PREFERENCE MAMMOGRAPHY SYSTEM	Mar 31, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K945241	LORAD M-IV, LORAD M-IVI	Mar 31, 1995	Substantially Equivalent	LORAD CORP.
K941353	MAM-CH22S MAMMOGRAPHY SYSTEM WITH OPTIONAL MAMMOGUIDE STERIOTACTIC BIOPSY SYSTEM	Mar 31, 1995	Substantially Equivalent	ELSCINT, INC.
K945619	ATHENA HFX	Mar 23, 1995	Substantially Equivalent	FISCHER IMAGING CORP.
K950608	DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION	Mar 02, 1995	Substantially Equivalent	LORAD CORP.
K944816	SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096)	Feb 08, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K932356	NOVA XM2	Feb 08, 1995	Substantially Equivalent	DYNARAD CORP.
K934478	ALPHA STEREO	Jan 31, 1995	Substantially Equivalent	INSTRUMENTARIUM CORP.
K945496	MAMMOGRAPHIC X-RAY UNIT	Dec 27, 1994	Substantially Equivalent	LORAD CORP.
K945272	RHODIUM FILTER	Dec 14, 1994	Substantially Equivalent	LORAD CORP.
K935428	BENNETT X-RAY DIGITAL SPOT IMAGER	Nov 01, 1994	Substantially Equivalent	BENNETT X-RAY TECHNOLOGIES
K934868	LORAD TRANSPO	Oct 14, 1994	Substantially Equivalent	LORAD CORP.
K933430	CYTOGUIDE STEREOTATIC BIOPSY SYSTEM	Sep 22, 1994	Substantially Equivalent	GOLD COAST IMAGING, INC.
K932672	MAMMOMAT 300 AND MAMMOMAT 3000	Sep 14, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K934831	ADVANCED AUTOMATIC KV	Aug 23, 1994	Substantially Equivalent	ELSCINT, INC.
K935608	MAMOSPAT	May 17, 1994	Substantially Equivalent	E.V.S. TOOL & DIE CO., INC.
K936161	SYSTEM, X-RAY, MAMOGRAPHIC	May 04, 1994	Substantially Equivalent	TECHNOWIPE
K940701	BENNETT MAMMOGRAPHY POSITIONING CHAIR MODEL NO. M-PCH	Apr 28, 1994	Substantially Equivalent	BENNETT X-RAY CORP.
K934373	MOBILE SOPHIE MODIFICATION	Apr 07, 1994	Substantially Equivalent	PLANMED OY
K934870	LORAD D-550	Jan 31, 1994	Substantially Equivalent	LORAD CORP.
K934748	LORAD M-IIE MODIFICATION	Jan 31, 1994	Substantially Equivalent	LORAD CORP.
K934625	LORAD M-III	Jan 28, 1994	Substantially Equivalent	LORAD CORP.
K933754	CHENOWETH-FRANK RADIOPATHOLOGICAL GRID	Sep 20, 1993	Substantially Equivalent	COOK, INC.
K930282	AVIVA F22/MAM-CH22 W/OPTIONAL CYTOGUIDE BIOPSY SYS	Aug 23, 1993	Substantially Equivalent	ELSCINT, INC.
K925725	CONTOUR MAMMOGRAPHY SYSTEM, MODEL NUMBER M-CTR	Feb 26, 1993	Substantially Equivalent	BENNETT X-RAY CORP.
K925212	GIOTTO PATIENT BED	Jan 15, 1993	Substantially Equivalent	GOLD COAST IMAGING, INC.
K923471	PLANMED CYTOGUIDE	Nov 24, 1992	Substantially Equivalent	PLANMED OY
K921962	LORAD DIGITAL SPOT MAMMOGRAPHY	Nov 23, 1992	Substantially Equivalent	LORAD MEDICAL SYSTEMS, INC.
K921986	PATIENT INFORMATION MANAGER (PIM)	Oct 16, 1992	Substantially Equivalent	CONTINENTAL X-RAY CORP.
K922454	MOBILE ATHENA HF	Sep 11, 1992	Substantially Equivalent	FISCHER IMAGING CORP.
K923061	MAMMOSCAN	Sep 10, 1992	Substantially Equivalent	FISCHER IMAGING CORP.
K920470	MEYER FOREIGN BODY LOCATOR	Aug 26, 1992	Substantially Equivalent	SEYMOUR W. MEYER
K921896	TILTING MAG	Aug 03, 1992	Substantially Equivalent	CONTINENTAL X-RAY CORP.
K915201	CYTOGUIDE STEREOTACTIC BIOPSY SYSTEM MODEL MF-CYTO	Jul 28, 1992	Substantially Equivalent	BENNETT X-RAY CORP.
K922619	DIGITIZER, MODEL # 3-000A-1518	Jul 01, 1992	Substantially Equivalent	LORAD MEDICAL SYSTEMS, INC.
K920938	VJW2919 PNEUMATIC COMPRESSION UPGRADE	Jun 17, 1992	Substantially Equivalent	VARIAN CANADA, INC.
K915748	AVIVA MAMMOGRAPHIC X-RAY SYSTEM	Feb 04, 1992	Substantially Equivalent	ELSCINT, INC.
K913732	MAMMOGRAPHIC X-RAY SYSTEM	Feb 03, 1992	Substantially Equivalent	LORAD MEDICAL SYSTEMS, INC.
K913418	SENOGRAPHE DMR/SMR/DM	Jan 06, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K913845	PHILIPS MAMMODIAGNOST BC	Dec 20, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K914328	MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM	Dec 02, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K910111	VARIOUS MODELS OF DAYLIGHT CASSETTE HOLDERS	Sep 23, 1991	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K912974	MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM	Sep 19, 1991	Substantially Equivalent	ELSCINT, INC.
K896596	ALPHA III PLUS AND MODEL P2500F/101 W/OPTIONAL	May 30, 1991	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K904953	PLANMED SOPHIE	Apr 18, 1991	Substantially Equivalent	PLANMECA USA, INC.
K905748	MAMEX DC AMI SL12/MG15	Mar 07, 1991	Substantially Equivalent	SOREDEX, INC.
K904517	MAMMOSPOT 3 AND MAMMOSPOT 8	Nov 15, 1990	Substantially Equivalent	AMERICAN MAMMOGRAPHICS, INC.
K903651	AMI MAMMOSPOT	Nov 15, 1990	Substantially Equivalent	AMERICAN MAMMOGRAPHICS, INC.
K901558	GIOTTO MAMMOGRAPHY HF	Jul 03, 1990	Substantially Equivalent	MEDICAL DEVICE MARKETING NETWORK, INC.
K901997	X-RAY TUBE HOUSING ASSEMBLY, VARIOUS MODELS	Jun 06, 1990	Substantially Equivalent	COMET LTD. C/O RADIOLOGY RESOURCES, INC.
K900989	ATHENA-HF MAMMOGRAPHIC X-RAY SYSTEM	Mar 28, 1990	Substantially Equivalent	FISCHER IMAGING CORP.
K896609	CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC	Jan 31, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K892342	TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM	Nov 17, 1989	Substantially Equivalent	BAY SHORE MEDICAL EQUIPMENT CORP.
K884107	STEREOTACTIC BIOPSY ATTACHMENT	May 05, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K890784	MAMMOMAT C	May 03, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K885020	CYTOGUIDE	Apr 26, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K891090	SPECBOARD	Apr 07, 1989	Substantially Equivalent	MACBRUD CORP. MEDICAL DIV.
K884345	MODEL ESP-200 MAMMOGRAPHIC SYSTEM	Mar 23, 1989	Substantially Equivalent	ACOMA MEDICAL IMAGING, INC.
K890483	THE PATHFINDER SYSTEM	Mar 14, 1989	Substantially Equivalent	DENMARK ASSOC.
K885135	MICRO-FINE HIGH FREQ. MOBILE MAMMO. SYSTEM MF-150	Mar 09, 1989	Substantially Equivalent	BENNETT X-RAY CORP.
K884917	RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM	Mar 09, 1989	Substantially Equivalent	AMG MEDICAL EQUIPMENTS, INC.
K884677	MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.	Jan 06, 1989	Substantially Equivalent	ELSCINT, INC.
K884676	MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.	Jan 06, 1989	Substantially Equivalent	ELSCINT, INC.
K882875	STEREOTACTIC BREAST LESION LOCALIZATION ACCESSORY	Nov 07, 1988	Substantially Equivalent	LORAD MEDICAL SYSTEMS, INC.
K882133	MAMMO M	Sep 19, 1988	Substantially Equivalent	ZIEHM INTERNATIONAL, INC.
K881697	BREAST LESION LOCALIZATION NEEDLE	Sep 14, 1988	Substantially Equivalent	BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
K881506	MAMEX DC MAG MG12	Jun 10, 1988	Substantially Equivalent	ORION CORP.
K881505	MAMEX DC MG11	Jun 10, 1988	Substantially Equivalent	ORION CORP.
K881882	SENOGRAPHE 600T AND 600TS SENIX HF	May 25, 1988	Substantially Equivalent	GENERAL ELECTRIC CO.
K880531	MAMMOGRAPHIC X-RAY SYSTEM ATHENA	May 02, 1988	Substantially Equivalent	FISCHER IMAGING CORP.
K880905	MAMMOGRAPHY MOVING GRID BUCKY	Mar 21, 1988	Substantially Equivalent	CUSTOM MEDICAL PRODUCTS, LTD.
K875377	SHIMADZU MAMMOGRAPHIC STAND MR-30	Feb 12, 1988	Substantially Equivalent	SHIMADZU PRECISION INSTRUMENTS, INC.
K874040	MAMEX DC S SL10/MG14	Nov 23, 1987	Substantially Equivalent	ORION CORP.
K873618	STEREOTIX	Nov 16, 1987	Substantially Equivalent	THOMSON-CGR MEDICAL CORP.
K873836	MAMMOGRAPHIC KVP METER MODEL 232	Oct 16, 1987	Substantially Equivalent	RADIATION MEASUREMENTS, INC.
K872734	MAMMOGRAPH MAMMOGRAPHIC X-RAY DEVICE	Oct 08, 1987	Substantially Equivalent	PALOMEX INSTRUMENTARIUM CORP.
K871048	MICRO MAMMO I MAMMOGRAPHY UNIT	Sep 01, 1987	Substantially Equivalent	AMERASIA IMPORT-EXPORT, INC.
K872980	MAM-CP X-RAY APPARATUS	Aug 27, 1987	Substantially Equivalent	TRANSWORLD X-RAY CORP.
K871592	RF-1 CIRCUIT	May 22, 1987	Substantially Equivalent	DIAGNOSTIC IMAGING SPECIALISTS CORP.
K864958	ALPHA II DIAGNOSTIC X-RAY	Jan 30, 1987	Substantially Equivalent	AUSONICS PTY LTD.
K861692	FISCHER PPS/MAMMOTEST MAMMOGRAPHY SYSTEM	Dec 15, 1986	Substantially Equivalent	FISCHER IMAGING CORP.
K863710	ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT	Oct 14, 1986	Substantially Equivalent	AUSONICS PTY LTD.
K860129	ISO-MAMMO	Mar 06, 1986	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K854203	TEC 2720 MAMEX DC MAG	Mar 06, 1986	Substantially Equivalent	TECNOMED, INC.
K854510	MINXRAY 500M MAMMOGRAPHIC SYSTEM	Jan 01, 1986	Substantially Equivalent	MINXRAY, INC.
K853395	RMS-1000 A.K.A. RAYTHEON MEDICAL SYSTEMS-1000	Nov 01, 1985	Substantially Equivalent	RAYTHEON MEDICAL SYSTEMS
K844119	MAMMOGRAPH III	Jul 19, 1985	Substantially Equivalent	AMERICAN MEDICAL IMPORTS, INC.
K850173	AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT	Apr 16, 1985	Substantially Equivalent	AUSONICS PTY LTD.
K850614	SAND S MB12 MAMMOGRAPHY MOVING GRID BUCKY	Mar 26, 1985	Substantially Equivalent	S & S X-RAY PRODUCTS, INC.
K843437	MEI MAMMOGRAPHY SYS MX-2049	Nov 27, 1984	Substantially Equivalent	MOTI ENTERPRISES, INC.
K842102	LORAD	Jul 17, 1984	Substantially Equivalent	LORAD MEDICAL SYSTEMS, INC.
K841774	UNIMACS, PATENT PENDING UNIVERSAL MAM	Jun 26, 1984	Substantially Equivalent	TECHNICAL DEVICES FOR MEDICINE
K833243	MAMMOGRAPHIC S-RAY SYSTEM	Oct 28, 1983	Substantially Equivalent	XEROX MEDICAL SYSTEMS
K832733	XEROX 120 SYS MAMMOGRAPHIC X-RAY	Sep 29, 1983	Substantially Equivalent	XEROX MEDICAL SYSTEMS
K790273	MAMMOGRAPHY SYSTEM AND CASSETTE	Mar 21, 1979	Substantially Equivalent	AGFA-GEVAERT, INC.
K770693	X-RAY DEVICE, MAMMOGRAPHIC DIAGNOSTIC	Aug 03, 1977	Substantially Equivalent	XONICS MEDICAL SYSTEMS, INC.

FEI Numbers

This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

1000132370: 44 registrations

1000138054: 760 registrations

1000284313: 125 registrations

1047843: 371 registrations

1052243: 2 registrations

2020678: 3 registrations

2243072: 162 registrations

2649711: 33 registrations

3000204334: 9 registrations

3001556265: 44 registrations

3001722928: 110 registrations

3002807317: 8 registrations

3003772619: 12 registrations

3003775006: 32 registrations

3004977335: 291 registrations

3005496266: 37 registrations

3005810333: 50 registrations

3007014520: 30 registrations

3007321367: 2 registrations

3008002452: 202 registrations

3008496839: 60 registrations

3008632256: 13 registrations

3009196578: 99 registrations

3009470597: 9 registrations

3009617712: 165 registrations

3010703925: 45 registrations

3015276088: 90 registrations

Registration Numbers

This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.

1047843: 371 registrations

1052243: 2 registrations

1056553: 44 registrations

1319639: 760 registrations

1423507: 202 registrations