The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Insight 7000 Phased Array Torso Coil.
| Device ID | K972340 |
| 510k Number | K972340 |
| Device Name: | INSIGHT 7000 PHASED ARRAY TORSO COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | USA INSTRUMENTS, INC. 675-B ALPHA DR. Highland Heights, OH 44143 |
| Contact | Rony Thomas |
| Correspondent | Rony Thomas USA INSTRUMENTS, INC. 675-B ALPHA DR. Highland Heights, OH 44143 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-24 |
| Decision Date | 1997-08-21 |
| Summary: | summary |