Device product

I-View¿ Contrast Enhanced Digital Mammography, ASY-08109

Z-0685-2019

December 06, 2018

Class II

Product summary

Firm: Hologic, Inc.
Event: Event 81700
Status: Terminated
Classification: Class II
Quantity: 337 units
Official record key: device-enforcement:Z-0685-2019

Official wording

Reason: Calibration issue not possible to visualize contrast uptake in the subtracted mammography images

Code information: Model Number: ASY-08109 UDI Number: 15420045512016 All units

Distribution pattern: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Calibration issue not possible to visualize contrast uptake in the subtracted mammography images