Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Resonex, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
153 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935369 | FAST SPIN ECHO (FSE) | Resonex, Inc. | 1994-03-21 | 137 | 0 |
| K935570 | NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM | Resonex, Inc. | 1994-03-16 | 118 | 0 |
| K931392 | ECG GATING UNIT | Resonex, Inc. | 1993-11-02 | 228 | 0 |
| K923870 | 3DTOF MRA | Resonex, Inc. | 1993-01-12 | 162 | 0 |
| K924154 | KINEMATIC MRI MOVIEMAKER | Resonex, Inc. | 1992-11-23 | 97 | 0 |
| K923823 | 3D IMAGING | Resonex, Inc. | 1992-10-30 | 92 | 0 |
| K922677 | MAGNETIZATION TRANSFER CONTRAST | Resonex, Inc. | 1992-09-04 | 92 | 0 |
| K920254 | COILS FOR RX4000 & RX5000 MRI SYSTEMS | Resonex, Inc. | 1992-06-22 | 153 | 0 |
| K921046 | BO POWER SUPPLY | Resonex, Inc. | 1992-05-28 | 85 | 0 |
| K920835 | PRESATURATION | Resonex, Inc. | 1992-05-22 | 88 | 0 |
| K915754 | 16 BIT A/D | Resonex, Inc. | 1992-03-16 | 84 | 0 |
| K914114 | 2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA) | Resonex, Inc. | 1991-12-04 | 82 | 0 |
| K913325 | 40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE | Resonex, Inc. | 1991-11-01 | 99 | 0 |
| K911800 | COIL FIELD EXTENDER | Resonex, Inc. | 1991-07-03 | 71 | 0 |
| K911892 | RX-5000 MRI SYSTEM | Resonex, Inc. | 1991-06-20 | 55 | 0 |
| K910269 | 10 ADJUSTABLE BELT COIL | Resonex, Inc. | 1991-04-08 | 76 | 0 |
| K902630 | BILATERAL TMJ COIL | Resonex, Inc. | 1990-07-19 | 35 | 0 |
| K901602 | VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000 | Resonex, Inc. | 1990-05-07 | 31 | 0 |
| K894974 | MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM | Resonex, Inc. | 1989-09-12 | 36 | 0 |
| K892959 | VERSION 4.2 APPLICATION SOFTWARE | Resonex, Inc. | 1989-06-01 | 38 | 0 |
| K883737 | VFQ HEAD COIL | Resonex, Inc. | 1988-10-13 | 42 | 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