Toshiba America Mri, Inc.
S. San Francisco, CA, US
Toshiba America Mri, Inc. appears in FDA device records in S. San Francisco, CA. FDA records list 68 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 68
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 68FDA records hold 68 510(k) clearances for Toshiba America Mri, Inc. between 1990 and 2000. The busiest year on record is 1990, with 18. The most recent is 2000, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1990 | 18 |
| 1991 | 4 |
| 1992 | 10 |
| 1993 | 5 |
| 1994 | 5 |
| 1995 | 6 |
| 1996 | 6 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 6 |
| 2000 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K002531 | EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3 | LNH | Substantially Equivalent | |
| K002522 | OPART, MODEL MRT-600 | MOS | Substantially Equivalent | |
| K000549 | OPART, MODEL MRT-600 | MOS | Substantially Equivalent | |
| K993803 | EXCELART WITH PIANISSIMO | LNH | Substantially Equivalent | |
| K993574 | OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON | LNH | Substantially Equivalent | |
| K991740 | OPART, MODEL MRT-600 | MOS | Substantially Equivalent | |
| K991057 | EXTRA LARGE BODY COIL FOR OPART (MRT-600) | MOS | Substantially Equivalent | |
| K990620 | EXCELART | LNH | Substantially Equivalent | |
| K990260 | OPART | LNH | Substantially Equivalent | |
| K990007 | OPART, MODEL MRT-600 | MOS | Substantially Equivalent | |
| K983110 | FLEXART,FLEXART/HYPER, VISART, VISART/HYPER | LNH | Substantially Equivalent | |
| K981475 | OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE | LNH | Substantially Equivalent | |
| K970573 | FLEXART V3.5 SOFTWARE | LNH | Substantially Equivalent | |
| K964608 | MRT-35A V9.0 | LNH | Substantially Equivalent | |
| K962138 | FLEXART V3.1 SOFTWARE | LNH | Substantially Equivalent | |
| K962933 | OPART MRT-600 | LNH | Substantially Equivalent | |
| K961624 | FLEXART TMJ COIL | LNH | Substantially Equivalent | |
| K961842 | SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K961391 | FLEXART QD HEAD/NECK COIL | MOS | Substantially Equivalent | |
| K961238 | MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1 | LNH | Substantially Equivalent | |
| K945875 | MRT-50 QD BODY COIL | LNH | Substantially Equivalent | |
| K945798 | MRT-35A UPGRADE 8.0CD | LNH | Substantially Equivalent | |
| K945665 | FLEXART(TM) QD C-SPINE COIL | LNH | Substantially Equivalent | |
| K946244 | ACCESS(TM) COMPASS BED | LNH | Substantially Equivalent | |
| K941864 | MRT-150A, MRT-150A SOFTWARE VERSION 11.9 | LNH | Substantially Equivalent | |
| K944662 | FLEXART QD BODY COIL | LNH | Substantially Equivalent | |
| K943021 | MRT-150A | LNH | Substantially Equivalent | |
| K942609 | MRT-150A SHOULDER COIL | LNH | Substantially Equivalent | |
| K940796 | ACCESS | LNH | Substantially Equivalent | |
| K933018 | MRT-50GP | LNH | Substantially Equivalent | |
| K935084 | INCREASED SAR PACKAGE FOR MRT-150A | LNH | Substantially Equivalent | |
| K930960 | ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY | LNH | Substantially Equivalent | |
| K926001 | MRT-50A, MRT-150A | LNH | Substantially Equivalent | |
| K925286 | MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE | LNH | Substantially Equivalent | |
| K926171 | MRT-150A, QD SPINE COIL | LNH | Substantially Equivalent | |
| K924808 | MRT-50A SUPER | LNH | Substantially Equivalent | |
| K921940 | MRT-35(TM) | LNH | Substantially Equivalent | |
| K922798 | QD WHOLE BODY COIL, MRT-150A | LNH | Substantially Equivalent | |
| K921413 | MRT-50 | LNH | Substantially Equivalent | |
| K921720 | MRT-50A QD SPINE COIL | LNH | Substantially Equivalent | |
| K920096 | MRT-150 QD KNEE COIL | LNH | Substantially Equivalent | |
| K920098 | ACCESS QD HEAD COIL | LNH | Substantially Equivalent | |
| K920095 | MRT-50 MULTIVIEW COIL | LNH | Substantially Equivalent | |
| K920126 | MRT-50 FLEXIBLE BODY COIL | LNH | Substantially Equivalent | |
| K920125 | MRT-50 SPINE COIL | LNH | Substantially Equivalent | |
| K920097 | MRT-50 QD HEAD COIL | LNH | Substantially Equivalent | |
| K914012 | MRT-150A | LNH | Substantially Equivalent | |
| K911276 | MAGNETIC RESONANCE DEVICE ACCESSORY | LNH | Substantially Equivalent | |
| K911495 | MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A) | LNH | Substantially Equivalent | |
| K910220 | MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL | LNH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain