Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Information, Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801166 | PET-SCOPE II MODEL DIS-1611 | Diagnostic Information, Inc. | 1980-06-26 | 41 | 0 |
| K771485 | PET-TV X-RAY IMAGE INTENSIFIER SYSTEM | Diagnostic Information, Inc. | 1977-08-16 | 14 | 0 |
| K761285 | PET-SCOPE | Diagnostic Information, Inc. | 1976-12-29 | 9 | 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