Chicago X-Ray Systems

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• Categories: Other Medical Devices

Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

Class I - Dangerous

The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also, the user's manual was found to have missing or improperly labeled information as required by 21 CFR 1020.30(h).

Jul 3, 2012 Other Medical Devices Nationwide View Details →