The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Symphony 360 Remote Control Table.
| Device ID | K981227 |
| 510k Number | K981227 |
| Device Name: | SYMPHONY 360 REMOTE CONTROL TABLE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Jim Lambrecht |
| Correspondent | Jim Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-03 |
| Decision Date | 1998-06-30 |