Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Toshiba America Mri, Inc. · Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
203 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 | Toshiba America Mri, Inc. | 2000-10-26 | 71 | 4 |
| K002522 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 2000-10-25 | 71 | 0 |
| K000549 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 2000-04-20 | 62 | 0 |
| K993803 | EXCELART WITH PIANISSIMO | Toshiba America Mri, Inc. | 2000-02-06 | 89 | 3 |
| K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON | Toshiba America Mri, Inc. | 2000-01-18 | 89 | 0 |
| K991740 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 1999-08-02 | 73 | 0 |
| K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) | Toshiba America Mri, Inc. | 1999-05-20 | 51 | 0 |
| K990620 | EXCELART | Toshiba America Mri, Inc. | 1999-05-14 | 78 | 5 |
| K990260 | OPART | Toshiba America Mri, Inc. | 1999-04-15 | 78 | 0 |
| K990007 | OPART, MODEL MRT-600 | Toshiba America Mri, Inc. | 1999-04-01 | 87 | 0 |
| K983110 | FLEXART,FLEXART/HYPER, VISART, VISART/HYPER | Toshiba America Mri, Inc. | 1999-02-25 | 174 | 0 |
| K981475 | OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE | Toshiba America Mri, Inc. | 1998-07-14 | 81 | 0 |
| K970573 | FLEXART V3.5 SOFTWARE | Toshiba America Mri, Inc. | 1997-07-21 | 157 | 0 |
| K964608 | MRT-35A V9.0 | Toshiba America Mri, Inc. | 1997-02-04 | 78 | 0 |
| K962138 | FLEXART V3.1 SOFTWARE | Toshiba America Mri, Inc. | 1996-12-23 | 203 | 0 |
| K962933 | OPART MRT-600 | Toshiba America Mri, Inc. | 1996-10-25 | 88 | 0 |
| K961624 | FLEXART TMJ COIL | Toshiba America Mri, Inc. | 1996-10-18 | 175 | 0 |
| K961842 | SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMA | Toshiba America Mri, Inc. | 1996-08-02 | 81 | 0 |
| K961391 | FLEXART QD HEAD/NECK COIL | Toshiba America Mri, Inc. | 1996-07-09 | 90 | 0 |
| K961238 | MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1 | Toshiba America Mri, Inc. | 1996-06-28 | 88 | 0 |
| K945875 | MRT-50 QD BODY COIL | Toshiba America Mri, Inc. | 1995-04-20 | 140 | 0 |
| K945665 | FLEXART(TM) QD C-SPINE COIL | Toshiba America Mri, Inc. | 1995-04-06 | 140 | 0 |
| K945798 | MRT-35A UPGRADE 8.0CD | Toshiba America Mri, Inc. | 1995-04-06 | 129 | 0 |
| K946244 | ACCESS(TM) COMPASS BED | Toshiba America Mri, Inc. | 1995-02-08 | 48 | 0 |
| K941864 | MRT-150A, MRT-150A SOFTWARE VERSION 11.9 | Toshiba America Mri, Inc. | 1995-01-26 | 283 | 0 |
| K944662 | FLEXART QD BODY COIL | Toshiba America Mri, Inc. | 1995-01-25 | 126 | 0 |
| K943021 | MRT-150A | Toshiba America Mri, Inc. | 1994-10-14 | 112 | 0 |
| K942609 | MRT-150A SHOULDER COIL | Toshiba America Mri, Inc. | 1994-09-02 | 92 | 0 |
| K940796 | ACCESS | Toshiba America Mri, Inc. | 1994-08-23 | 182 | 0 |
| K933018 | MRT-50GP | Toshiba America Mri, Inc. | 1994-02-18 | 241 | 2 |
| K935084 | INCREASED SAR PACKAGE FOR MRT-150A | Toshiba America Mri, Inc. | 1994-02-09 | 107 | 0 |
| K930960 | ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY | Toshiba America Mri, Inc. | 1993-11-01 | 250 | 0 |
| K926001 | MRT-50A, MRT-150A | Toshiba America Mri, Inc. | 1993-10-08 | 315 | 0 |
| K925286 | MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE | Toshiba America Mri, Inc. | 1993-10-07 | 352 | 0 |
| K924808 | MRT-50A SUPER | Toshiba America Mri, Inc. | 1993-04-27 | 215 | 0 |
| K926171 | MRT-150A, QD SPINE COIL | Toshiba America Mri, Inc. | 1993-04-27 | 140 | 0 |
| K921940 | MRT-35(TM) | Toshiba America Mri, Inc. | 1992-11-10 | 200 | 0 |
| K922798 | QD WHOLE BODY COIL, MRT-150A | Toshiba America Mri, Inc. | 1992-09-14 | 96 | 0 |
| K921413 | MRT-50 | Toshiba America Mri, Inc. | 1992-08-14 | 143 | 0 |
| K921720 | MRT-50A QD SPINE COIL | Toshiba America Mri, Inc. | 1992-07-16 | 98 | 0 |
| K920096 | MRT-150 QD KNEE COIL | Toshiba America Mri, Inc. | 1992-07-10 | 184 | 0 |
| K920098 | ACCESS QD HEAD COIL | Toshiba America Mri, Inc. | 1992-06-09 | 153 | 0 |
| K920095 | MRT-50 MULTIVIEW COIL | Toshiba America Mri, Inc. | 1992-04-28 | 111 | 0 |
| K920126 | MRT-50 FLEXIBLE BODY COIL | Toshiba America Mri, Inc. | 1992-04-06 | 87 | 0 |
| K920097 | MRT-50 QD HEAD COIL | Toshiba America Mri, Inc. | 1992-03-31 | 83 | 0 |
| K920125 | MRT-50 SPINE COIL | Toshiba America Mri, Inc. | 1992-03-31 | 81 | 0 |
| K914012 | MRT-150A | Toshiba America Mri, Inc. | 1991-11-27 | 79 | 0 |
| K911276 | MAGNETIC RESONANCE DEVICE ACCESSORY | Toshiba America Mri, Inc. | 1991-06-28 | 95 | 0 |
| K911495 | MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A) | Toshiba America Mri, Inc. | 1991-06-21 | 78 | 0 |
| K910220 | MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL | Toshiba America Mri, Inc. | 1991-03-25 | 67 | 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