Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scanditronix, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
342 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934303 | RFA A-300 | Scanditronix, Inc. | 1994-08-09 | 342 | 0 |
| K942092 | DPD-3 | Scanditronix, Inc. | 1994-07-29 | 88 | 0 |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Scanditronix, Inc. | 1993-01-04 | 83 | 0 |
| K914926 | SCANDIPLAN - VERSION 338 | Scanditronix, Inc. | 1992-05-28 | 206 | 0 |
| K904753 | DIOLASE | Scanditronix, Inc. | 1990-11-09 | 21 | 0 |
| K900434 | MM-22 MICROTRON, MM50 MICROTRON | Scanditronix, Inc. | 1990-10-23 | 266 | 0 |
| K843366 | SUPERPETT | Scanditronix, Inc. | 1984-11-21 | 85 | 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