Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IXG · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913243 | BENNETT X-RAY HORIZ RADIO FLOAT/HI-LO ELEV TABLE | Bennett X-Ray Corp. | 1991-09-19 | 59 | 0 |
| K852528 | BONE DENSITY CT PHANTOM | Computerized Imaging Reference Systems, Inc. | 1985-09-26 | 104 | 0 |
| K840131 | COMPUTED TOMOGRAPHY CALIBRATION PHANT | Imatron, Inc. | 1984-02-21 | 42 | 0 |
| K834465 | SERIES OF DIAGNOSTIC PHANTOMS | Cirs, Inc. | 1984-02-21 | 63 | 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