Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Chicago X-Ray Systems, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972968 | ROTOGRAPH PLUS | Chicago X-Ray Systems, Inc. | 1997-10-08 | 58 | 0 |
| K954565 | EXPLOR-X (AZTEH) HF | Chicago X-Ray Systems, Inc. | 1995-10-27 | 25 | 0 |
| K950667 | AZTECH 65 WITH CCD (COMPUTER CONTROLLED DENSITY) TIMER | Chicago X-Ray Systems, Inc. | 1995-04-06 | 52 | 0 |
| K931300 | FLASH DENT | Chicago X-Ray Systems, Inc. | 1994-03-21 | 371 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda