FDA-Device2016-05-18Class II

NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Novarad Corporation
Hazard

The SUV values that are being calculated in the PET/CT fusion tool are incorrect.

Sold states
Nationwide. 3 Canadian and 33 foreign consignees. No VA/gov/military.
Affected count
2,386
Manufactured in
752 E 1180 S Ste 200, N/A, American Fork, UT, United States
Products
NovaPACS  Diagnostic Viewer versions 8.3.7, 8.4.2, 8.4.3, and 8.4.4. Novarad Corporation

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2016

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