FDA-Device2013-05-29Class II
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.
Chicago X-Ray Systems, Inc.
Hazard
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).
Sold states
Worldwide Distribution- USA (nationwide) and Latin America.
Affected count
1960 units
Manufactured in
65 E Palatine Rd Ste 121, N/A, Prospect Heights, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1179-2013Don't want to check this manually?
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