The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Autotune Device (atd Ii) For Picker Mri Systems.
| Device ID | K932292 |
| 510k Number | K932292 |
| Device Name: | AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Contact | John E Stevens |
| Correspondent | John E Stevens MEDRAD, INC. RTE.910 MEDRAD DRIVE, P.O. BOX 780 Indianola, PA 15051 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-10 |
| Decision Date | 1993-08-26 |