FDA-Device2019-01-02Class II
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Hologic, Inc.
Hazard
Calibration issue not possible to visualize contrast uptake in the subtracted mammography images
Sold states
Nationwide Foreign: Australia Austria Belgium Brazil Canada China Colombia Ecuador Egypt France Germany Greece Hong Kong India Ireland Israel Italy Japan Korea, Republic of Kuwait Malaysia Mexico Netherlands Pakistan Peru Poland Portugal Saudi Arabia Singapore Slovakia South Africa Spain Switzerland Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom
Affected count
337 units
Manufactured in
36 and 37 Apple Ridge Rd, Danbury, CT, United States
Products
I-View¿ Contrast Enhanced Digital Mammography, ASY-08109
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0685-2019Don't want to check this manually?
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