Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neurosoft, 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) |
|---|---|---|---|---|---|
| K011241 | NEUROSOFT'S SOURCE | Neurosoft, Inc. | 2001-09-19 | 149 | 0 |
| K001781 | CURRY MULTIMODAL NEUROIMAGING SOFTWARE | Neurosoft, Inc. | 2001-02-05 | 237 | 0 |
| K001692 | NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 | Neurosoft, Inc. | 2000-11-24 | 175 | 0 |
| K000812 | NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) | Neurosoft, Inc. | 2000-05-17 | 65 | 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