Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Chicago X-Ray Systems with 4 510(k) clearances and 1 device recall. The most recent is a device recall dated Jul 3, 2012: Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray ….
| Jul 3, 2012 | Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral source X-ray system for dental radiographic examination and diagnClass II · The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR 1010.2 & 1010.3. Also | Device recalls |
| Oct 8, 1997 | ROTOGRAPH PLUSK972968 · EHD | 510(k) clearances |
| Oct 27, 1995 | EXPLOR-X (AZTEH) HFK954565 · EAP | 510(k) clearances |
| Apr 6, 1995 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMERK950667 · EAP | 510(k) clearances |
| Mar 21, 1994 | FLASH DENTK931300 · EHD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
