Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Keystone X-Ray, 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) |
|---|---|---|---|---|---|
| K931486 | INTREX VSK INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-11-23 | 244 | 0 |
| K930925 | INTREX INTERORAL DENTAL X-RAY UNIT | Keystone X-Ray, Inc. | 1993-07-13 | 140 | 0 |
| K883354 | VARIABLE KV INTREX VSK 60 - 90 KVP | Keystone X-Ray, Inc. | 1988-12-21 | 134 | 0 |
| K812217 | FLUORO AUTOMATIC BRIGHTNESS SYS | Keystone X-Ray, Inc. | 1981-09-16 | 42 | 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