Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neocoil — 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) |
|---|---|---|---|---|---|
| K073236 | NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE | Neocoil | 2007-11-30 | 14 | 0 |
| K071611 | NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | 2007-06-28 | 15 | 0 |
| K071311 | NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL | Neocoil | 2007-05-22 | 13 | 0 |
| K070778 | NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL | Neocoil | 2007-04-11 | 21 | 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