The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for 1.5t 16 Channel Brain-spine Array Coil.
| Device ID | K052621 |
| 510k Number | K052621 |
| Device Name: | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Contact | Robert B Smith |
| Correspondent | Robert B Smith USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-23 |
| Decision Date | 2005-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682114547 | K052621 | 000 |