Mri Devices Corp.
Waukesha, WI, US
Mri Devices Corp. appears in FDA device records in Waukesha, WI. FDA records list 76 510(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
- 76
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 76FDA records hold 76 510(k) clearances for Mri Devices Corp. between 1991 and 2005. The busiest year on record is 2002, with 16. The most recent is 2005, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 2 |
| 1993 | 2 |
| 1996 | 2 |
| 1997 | 2 |
| 1999 | 8 |
| 2000 | 10 |
| 2001 | 11 |
| 2002 | 16 |
| 2003 | 11 |
| 2004 | 7 |
| 2005 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K050622 | HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL | MOS | Substantially Equivalent | |
| K050621 | NVA-127-8-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K050514 | MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS | MOS | Substantially Equivalent | |
| K050299 | HRK-123 KNEE ARRAY COIL | MOS | Substantially Equivalent | |
| K042103 | NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K041286 | DYNACAD V1.0 | LNH | Substantially Equivalent | |
| K041481 | MODEL BBC-127 BIOPSY BREAST COIL | MOS | Substantially Equivalent | |
| K040349 | MODIFICATION TO HRW-127 WRIST ARRAY COIL | MOS | Substantially Equivalent | |
| K040348 | MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K040288 | QSC-127-INT SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | |
| K033447 | CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 | NEU | Substantially Equivalent | |
| K033567 | MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS | MOS | Substantially Equivalent | |
| K032576 | BIOPSY BREAST COIL, MODEL BBC | MOS | Substantially Equivalent | |
| K033152 | HAC-12 AND HAC-30 HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K033151 | KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL | MOS | Substantially Equivalent | |
| K032633 | HRK-63-8 KNEE ARRAY COIL | MOS | Substantially Equivalent | |
| K032429 | QSC-127 SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | |
| K032090 | NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8 | MOS | Substantially Equivalent | |
| K024354 | PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS | MOS | Substantially Equivalent | |
| K024352 | HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM | MOS | Substantially Equivalent | |
| K024209 | QWH-250-PAN WRIST ARRAY COIL | MOS | Substantially Equivalent | |
| K024208 | OBC-250-PAN BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K023164 | BBC-63-GE BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K022910 | QSC-63-INT SHOULDER ARRAY COIL SET | MOS | Substantially Equivalent | |
| K022883 | HRK-63 KNEE ARRAY COIL | MOS | Substantially Equivalent | |
| K022720 | CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K022588 | HRW-63-INT WRIST ARRAY COIL | MOS | Substantially Equivalent | |
| K022488 | MODEL OBC-63 BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K022487 | MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL | MOS | Substantially Equivalent | |
| K022372 | HRH-127-8 HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K021631 | ISA-21 INTERVENTIONAL SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K021575 | OBC-127 BREAST ARRAY COIL | MOS | Substantially Equivalent | |
| K021570 | HNC-127-TRIO NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K020850 | GPF-29 GENERAL PURPOSE COIL SET | MOS | Substantially Equivalent | |
| K020606 | NVA-63-8 NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K020036 | EXS-63 SMALL EXTREMITY ARRAY COIL | MOS | Substantially Equivalent | |
| K013514 | PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K013602 | HNC-63-INT NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K013508 | HRH-127-ALLEGRA HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K013322 | HAC-420 HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K013159 | HRH-63-8 HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K013099 | MODIFICATION TO: QWH-420 WRIST ARRAY COIL | MOS | Substantially Equivalent | |
| K012353 | HNC-127 NEUROVASCULAR ARRAY COIL | MOS | Substantially Equivalent | |
| K003505 | KFA-127 KNEE, FOOT AND ANKLE ARRAY | MOS | Substantially Equivalent | |
| K010570 | BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160 | LNH | Substantially Equivalent | |
| K003899 | IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM | LNH | Substantially Equivalent | |
| K010140 | HRH-127 HEAD ARRAY COIL | MOS | Substantially Equivalent | |
| K003655 | PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL | MOS | Substantially Equivalent | |
| K002774 | HRH-63 HEAD ARRAY COIL | MOS | 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