Company ยท US
Chicago X-Ray Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 1997 | K972968 | ROTOGRAPH PLUS Chicago X-Ray Systems, Inc. | EHD |
| Oct 27, 1995 | K954565 | EXPLOR-X (AZTEH) HF Chicago X-Ray Systems, Inc. | EAP |
| Apr 6, 1995 | K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER Chicago X-Ray Systems, Inc. | EAP |
| Mar 21, 1994 | K931300 | FLASH DENT Chicago X-Ray Systems, Inc. | EHD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2013 | Chicago X-Ray Systems, Inc. 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. Terminated |
EAP | None listed |