The following data is part of a premarket notification filed by Mri Devices Corp. with the FDA for Model #qsc-200-4c And Qsc-165-4c Array Shoulder Coils.
| Device ID | K961366 |
| 510k Number | K961366 |
| Device Name: | MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Contact | Thomas Schubert |
| Correspondent | Thomas Schubert MRI DEVICES CORP. N8 W22520 JOHNSON DR., UNIT K JOHNSON DR., CORPORATE CENTER Waukesha, WI 53186 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-09 |
| Decision Date | 1996-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838080867 | K961366 | 000 |
| 00884838066441 | K961366 | 000 |
| 00884838066373 | K961366 | 000 |
| 00884838066250 | K961366 | 000 |
| 00884838065772 | K961366 | 000 |
| 00884838065765 | K961366 | 000 |
| 00884838065758 | K961366 | 000 |
| 00884838065741 | K961366 | 000 |