FDA Product Code IZH: System, X-ray, Mammographic
Leading manufacturers include Siemens Medical Solutions USA, Inc., General Electric Co. and Bd Becton Dickinson Vacutainer Systems Preanalytic.
176
Total
176
Cleared
114d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared System, X-ray, Mammographic Devices (Product Code IZH)
176 devices
Cleared
Jul 14, 2021
SMART FINDER
Ims Giotto S.P.A.
Radiology
226d
Cleared
Oct 05, 2020
Affirm Contrast Biopsy
Hologic, Inc.
Radiology
53d
Cleared
Jul 03, 2019
Biopsy Positioner
Fujifilm Corporation
Radiology
28d
Cleared
Feb 02, 2001
OPDIMA
Siemens Medical Solutions USA, Inc.
Radiology
43d
Cleared
May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
210d
Cleared
Sep 14, 1994
MAMMOMAT 300 AND MAMMOMAT 3000
Siemens Medical Solutions USA, Inc.
Radiology
469d
Cleared
Jan 06, 1992
SENOGRAPHE DMR/SMR/DM
General Electric Co.
Radiology
159d
Cleared
Dec 02, 1991
MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM
Siemens Medical Solutions USA, Inc.
Radiology
66d
Cleared
May 05, 1989
STEREOTACTIC BIOPSY ATTACHMENT
Siemens Medical Solutions USA, Inc.
Radiology
218d
Cleared
May 03, 1989
MAMMOMAT C
Siemens Medical Solutions USA, Inc.
Radiology
77d
Cleared
Sep 14, 1988
BREAST LESION LOCALIZATION NEEDLE
Bd Becton Dickinson Vacutainer Systems Preanalytic
Radiology
148d
Cleared
May 25, 1988
SENOGRAPHE 600T AND 600TS SENIX HF
General Electric Co.
Radiology
21d
About Product Code IZH - Regulatory Context
510(k) Submission Activity
176 total 510(k) submissions under product code IZH since 1977, with 176 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.