Chicago X-Ray Systems, Inc.
Wheeling, IL, US
Chicago X-Ray Systems, Inc. appears in FDA device records in Wheeling, IL. FDA records list 4 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Chicago X-Ray Systems, Inc. between 1994 and 1997. The busiest year on record is 1995, with 2. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K972968 | ROTOGRAPH PLUS | EHD | Substantially Equivalent | |
| K954565 | EXPLOR-X (AZTEH) HF | EAP | Substantially Equivalent | |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | EAP | Substantially Equivalent | |
| K931300 | FLASH DENT | EHD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1179-2013 | 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. | 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). | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain