The following data is part of a premarket notification filed by Avotec, Inc. with the FDA for Silent Scan.
| Device ID | K921891 |
| 510k Number | K921891 |
| Device Name: | SILENT SCAN |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AVOTEC, INC. P.O. BOX 1777 Jensen Beach, FL 34958 |
| Contact | Paul E Bullwinkel |
| Correspondent | Paul E Bullwinkel AVOTEC, INC. P.O. BOX 1777 Jensen Beach, FL 34958 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-22 |
| Decision Date | 1993-05-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SILENT SCAN 85789426 4578332 Live/Registered |
Avotec, Inc. 2012-11-28 |