Chicago X-Ray Systems, Inc.

Medical device manufacturer in Prospect Heights, IL.

4510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K972968Rotograph PlusEHD · Traditional 10/08/1997SE
K954565Explor-X (Azteh) HFEAP · Traditional 10/27/1995SE
K950667Aztech 65 with CCD (Computer Controlled Density) TimerEAP · Traditional 04/06/1995SE
K931300Flash DentEHD · Traditional 03/21/1994SE

Recalls

RecallProductInitiated
Z-1179-2013 Class IIFona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray…The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 &… 07/03/2012Terminated