FDA-Device2015-01-21Class II

IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

Sun Nuclear Corporation
Hazard

Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.

Sold states
Distributed in the states of CA, CO, and OH.
Affected count
6 Units.
Manufactured in
3275 Suntree Blvd, Melbourne, FL, United States
Products
IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2015

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