Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
X-Cel X-Ray Corp. — 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) |
|---|---|---|---|---|---|
| K993958 | IDX-60 INTRAORAL X-RAY | X-Cel X-Ray Corp. | 2000-02-14 | 84 | 0 |
| K930699 | M6-M | X-Cel X-Ray Corp. | 1993-08-09 | 180 | 0 |
| K871116 | X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R | X-Cel X-Ray Corp. | 1987-05-14 | 56 | 0 |
| K811230 | X-CELL X-RAY #'S P-75W/P-75M | X-Cel X-Ray Corp. | 1981-06-23 | 50 | 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