System, X-ray, Mammographic

Product Code: IZH

Radiology Medical Diagnostic X-Ray Equipment

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Diagnostic X-ray Systems And Their Major Components. [1020.30] Radiographic Equipment. [1020.31] Fluoroscopic Equipment. [1020.32] Computed Tomography (CT) Equipment. [1020.33]

Code of Federal Regulations: 892.1710


Radiation TypeIonizing
Radition SafetyProduct
Annual ReportsYes

Products Classified as IZH

5341System, X-ray, MammographicMammographic X-ray System.

Total Product Life Cycle (TPLC) Devices

5341System, X-ray, MammographicMammographic X-ray System.

FDA Consensus Standards

System, X-Ray, Mammographic [37174]21 CFR §892.1710 🔎

Pre-market Notifications for IZH

K203509SMART FINDERIMS Giotto S.p.A.
K191495Biopsy PositionerFUJIFILM Corporation
K161920Comfort CoverPRECISION DYNAMICS CORPORATION
K161575Affirm Lateral Arm Upright Biopsy AccessoryHOLOGIC
K153486Affirm Prone Biopsy SystemHologic Inc
K152038MammoGRIPWomen's Imaging Solutions Enterprises LLC
K123414SPECBOARD JR.MACBRUD CORP., MEDICAL DIVISION
K122836AFFIRM BREAST BIOPSY GUIDANCE SYSTEMLORAD, A HOLOGIC CO.
K113607BIOPSY DIGIT S BIOPSY SLGIOTTO USA, LLC
K113284BIOPSY POSITIONERFUJI FILM MEDICAL SYSTEMS
K103512AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC.
K101373EMBRACEIZI MEDICAL PRODUCTS INC.
K100692DIGITAL SPOT MAMMOGRAPHY SYSTEMHOLOGIC, INC.
K073262BELLABEEKLEY CORP.
K071787BEMITT, MODEL 0001DJA DISTRIBUTORS, LLC

Global Unique Device Identification Database

00815137021251System, X-Ray, Mammographic
00815137021244System, X-Ray, Mammographic
00815137020247System, X-Ray, Mammographic
00815137020230System, X-Ray, Mammographic
00841911101581System, X-Ray, Mammographic
07613327059281System, x-ray, mammographic
07613327059243System, x-ray, mammographic
07613327059182System, x-ray, mammographic
06430035430055System, X-Ray, Mammographic
05414904009802System, x-ray, mammographic
05414904009796System, x-ray, mammographic
05414904009345System, x-ray, mammographic
05414904008966System, x-ray, mammographic
05414904008959System, x-ray, mammographic
05414904008942System, x-ray, mammographic

Maude Adverse Events

AFFIRM PRONE BIOPSY SYSTEMHOLOGIC, INC2020-02-25
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2020-02-25
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2020-02-07
MULTICARE PLATINUMHOLOGIC, INC2020-01-29
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2020-01-21
MAMMOGRAM TESTUNK2019-11-25
MULTICARE PLATINUMHOLOGIC, INC2019-11-05
MULTICARE PLATINUMHOLOGIC, INC2019-11-05
MULTICARE PLATINUMHOLOGIC, INC2019-11-05
HOLOGIC DIMENSIONS MAMMOGRAPHY UNIT IN A MATHEWS COACH.HOLOGIC, INC.2019-10-28
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-09-23
MULTICARE PLATINUMHOLOGIC, INC2019-09-12
MULTICARE PLATINUMHOLOGIC, INC2019-08-23
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-08-13
MULTICARE PLATINUMHOLOGIC, INC2019-08-05
MULTICARE PLATINUMHOLOGIC, INC2019-07-29
FUJIFILM BIOPSY POSITIONERFUJIFILM CORPORATION2019-07-19
MULTICARE PLATINUMHOLOGIC, INC2019-07-16
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-06-25
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-06-18
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-06-04
MULTICARE PLATINUMHOLOGIC, INC2019-06-03
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-05-10
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-05-08
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-05-07
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-04-29
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-04-19
MULTICARE PLATINUMHOLOGIC, INC2019-04-12
MULTICARE PLATINUMHOLOGIC, INC2019-04-08
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-04-08
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-04-05
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-04-03
MULTICARE PLATINUMHOLOGIC, INC2019-03-13
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-03-13
MULTICARE PLATINUMHOLOGIC, INC2019-03-13
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC2019-02-21
AFFIRM BREAST BIOPSY GUIDANCE SYSTEMHOLOGIC, INC.2019-02-21
MULTICARE PLATINUMHOLOGIC, INC2019-02-15
MULTICARE PLATINUM2019-01-18
MULTICARE PLATINUMHOLOGIC, INC2019-01-15
AFFIRM PRONE BIOPSY SYSTEM, 3DHOLOGIC, INC2019-01-08
MULTICARE PLATINUMHOLOGIC, INC2019-01-04
AFFIRM PRONE BIOPSY SYSTEMHOLOGIC, INC2018-12-13
MULTICARE PLATINUMHOLOGIC, INC2018-12-11
MULTICARE PLATINUM STEREOTACTIC BREAST BIOPSY DEVICEHOLOGIC, INC.2018-11-27
2018-11-15
2018-11-15
MULTICARE PLATINUMHOLOGIC, INC2018-11-07
MAMMOTEST, BIOPSY TABLEDEVICOR MEDICAL PRODUCTS, INC.2018-10-19
MAMMOTOME MAMMOTEST SYSTEMDEVICOR MEDICAL PRODUCTS INC.2018-10-19
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