FDA-Device2021-08-25Class II

728332 IQon Spectral CT-Computed Tomography X-ray system

Philips North America Llc
Hazard

When setting patient weight unit preferences to pounds, SynchRight P3T (Personalized Patient Protocol) software will result in increased contrast volume, resulting in increased contrast volume recommended for the patient.

Sold states
US Nationwide distribution in the states of AZ, FL, LA, MN, NE, NV, NY, PA.
Affected count
N/A
Manufactured in
222 Jacobs St, N/A, Cambridge, MA, United States
Products
728332 IQon Spectral CT-Computed Tomography X-ray system

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2317-2021

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