Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Igc-Medical Advances, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
87 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041185 | TORSO ARRAY COIL, MODEL 558GE-64 | Igc-Medical Advances, Inc. | 2004-05-14 | 8 | 0 |
| K040640 | MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL | Igc-Medical Advances, Inc. | 2004-03-22 | 12 | 0 |
| K033292 | AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 | Igc-Medical Advances, Inc. | 2003-11-26 | 43 | 0 |
| K023848 | MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL | Igc-Medical Advances, Inc. | 2003-02-14 | 87 | 0 |
| K003366 | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL | Igc-Medical Advances, Inc. | 2000-12-22 | 53 | 0 |
| K001312 | MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL | Igc-Medical Advances, Inc. | 2000-06-20 | 55 | 0 |
| K000589 | MODEL 445SI-64E QUADRATURE WRIST COIL | Igc-Medical Advances, Inc. | 2000-03-14 | 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