Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuro Scan Labs — 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) |
|---|---|---|---|---|---|
| K001564 | SCAN LT40 (40 CHANNELS) | Neuro Scan Labs | 2000-11-24 | 189 | 0 |
| K001562 | NEURO SCAN MEDICAL SYSTEMS A4000 | Neuro Scan Labs | 2000-08-16 | 89 | 0 |
| K001324 | SYNAMPS (32-64 CHANNELS), ESI SYNAMPS (65-128 CHANNELS), ESI | Neuro Scan Labs | 2000-07-11 | 76 | 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