Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Mri Devices Corp. — Predicate Candidate Screening
71 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
26 daysmedian FDA review time
89 days90th percentile
71clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041286 | DYNACAD V1.0 | Mri Devices Corp. | 2004-07-21 | 69 | 0 |
| K041481 | MODEL BBC-127 BIOPSY BREAST COIL | Mri Devices Corp. | 2004-07-19 | 46 | 1 |
| K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | Mri Devices Corp. | 2004-03-09 | 26 | 0 |
| K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2004-03-09 | 26 | 0 |
| K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2004-03-05 | 28 | 0 |
| K033447 | CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /1 | Mri Devices Corp. | 2004-01-28 | 91 | 0 |
| K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | Mri Devices Corp. | 2003-11-25 | 15 | 0 |
| K032576 | BIOPSY BREAST COIL, MODEL BBC | Mri Devices Corp. | 2003-10-23 | 64 | 4 |
| K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL | Mri Devices Corp. | 2003-10-10 | 10 | 0 |
| K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL | Mri Devices Corp. | 2003-10-10 | 10 | 0 |
| K032633 | HRK-63-8 KNEE ARRAY COIL | Mri Devices Corp. | 2003-09-25 | 30 | 0 |
| K032429 | QSC-127 SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2003-08-21 | 15 | 0 |
| K032090 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 | Mri Devices Corp. | 2003-08-21 | 45 | 0 |
| K024354 | PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY CO | Mri Devices Corp. | 2003-01-09 | 10 | 0 |
| K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM | Mri Devices Corp. | 2003-01-09 | 10 | 0 |
| K024209 | QWH-250-PAN WRIST ARRAY COIL | Mri Devices Corp. | 2003-01-09 | 20 | 0 |
| K024208 | OBC-250-PAN BREAST ARRAY COIL | Mri Devices Corp. | 2003-01-07 | 18 | 1 |
| K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM | Mri Devices Corp. | 2002-10-11 | 21 | 0 |
| K023164 | BBC-63-GE BREAST ARRAY COIL | Mri Devices Corp. | 2002-10-11 | 18 | 0 |
| K022910 | QSC-63-INT SHOULDER ARRAY COIL SET | Mri Devices Corp. | 2002-10-03 | 30 | 0 |
| K022883 | HRK-63 KNEE ARRAY COIL | Mri Devices Corp. | 2002-09-27 | 28 | 0 |
| K022720 | CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL | Mri Devices Corp. | 2002-09-06 | 22 | 0 |
| K022588 | HRW-63-INT WRIST ARRAY COIL | Mri Devices Corp. | 2002-09-04 | 30 | 0 |
| K022487 | MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL | Mri Devices Corp. | 2002-08-23 | 25 | 0 |
| K022488 | MODEL OBC-63 BREAST ARRAY COIL | Mri Devices Corp. | 2002-08-23 | 25 | 1 |
| K021631 | ISA-21 INTERVENTIONAL SPINE ARRAY COIL | Mri Devices Corp. | 2002-08-13 | 88 | 0 |
| K022372 | HRH-127-8 HEAD ARRAY COIL | Mri Devices Corp. | 2002-08-13 | 22 | 0 |
| K021575 | OBC-127 BREAST ARRAY COIL | Mri Devices Corp. | 2002-06-12 | 29 | 0 |
| K021570 | HNC-127-TRIO NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2002-06-12 | 29 | 0 |
| K020850 | GPF-29 GENERAL PURPOSE COIL SET | Mri Devices Corp. | 2002-06-06 | 83 | 0 |
| K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2002-03-13 | 16 | 0 |
| K020036 | EXS-63 SMALL EXTREMITY ARRAY COIL | Mri Devices Corp. | 2002-02-01 | 28 | 0 |
| K013514 | PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | Mri Devices Corp. | 2002-01-02 | 72 | 0 |
| K013602 | HNC-63-INT NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2001-11-20 | 20 | 0 |
| K013508 | HRH-127-ALLEGRA HEAD ARRAY COIL | Mri Devices Corp. | 2001-11-20 | 29 | 0 |
| K013322 | HAC-420 HEAD ARRAY COIL | Mri Devices Corp. | 2001-10-16 | 11 | 0 |
| K013159 | HRH-63-8 HEAD ARRAY COIL | Mri Devices Corp. | 2001-10-16 | 25 | 0 |
| K013099 | MODIFICATION TO: QWH-420 WRIST ARRAY COIL | Mri Devices Corp. | 2001-09-25 | 8 | 0 |
| K012353 | HNC-127 NEUROVASCULAR ARRAY COIL | Mri Devices Corp. | 2001-08-14 | 20 | 0 |
| K003505 | KFA-127 KNEE, FOOT AND ANKLE ARRAY | Mri Devices Corp. | 2001-05-25 | 193 | 0 |
| K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 | Mri Devices Corp. | 2001-04-09 | 42 | 0 |
| K003899 | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM | Mri Devices Corp. | 2001-03-15 | 87 | 0 |
| K010140 | HRH-127 HEAD ARRAY COIL | Mri Devices Corp. | 2001-02-22 | 36 | 0 |
| K003655 | PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | Mri Devices Corp. | 2001-02-02 | 67 | 0 |
| K002774 | HRH-63 HEAD ARRAY COIL | Mri Devices Corp. | 2000-11-16 | 71 | 0 |
| K003331 | QWH-149 WRIST ARRAY COIL | Mri Devices Corp. | 2000-11-08 | 15 | 0 |
| K003340 | OBC-149 BREAST ARRAY COIL | Mri Devices Corp. | 2000-11-08 | 14 | 0 |
| K002602 | OBC-63 MEBREAST ARRAY COIL | Mri Devices Corp. | 2000-09-05 | 15 | 0 |
| K002539 | OBC-096 BREAST ARRAY COIL | Mri Devices Corp. | 2000-08-30 | 14 | 0 |
| K001944 | HAC-300 HEAD ARRAY COIL | Mri Devices Corp. | 2000-08-14 | 49 | 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