The following data is part of a premarket notification filed by Medical Advances, Inc. with the FDA for Phased Array Breast Coil.
| Device ID | K941025 |
| 510k Number | K941025 |
| Device Name: | PHASED ARRAY BREAST COIL |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Thomas E Tynes |
| Correspondent | Thomas E Tynes MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-04 |
| Decision Date | 1994-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838066212 | K941025 | 000 |