The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Tilting Radiographic Table (remote).
| Device ID | K963851 |
| 510k Number | K963851 |
| Device Name: | TILTING RADIOGRAPHIC TABLE (REMOTE) |
| Classification | Table, Radiographic, Tilting |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | James Lambrecht |
| Correspondent | James Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | IXR |
| CFR Regulation Number | 892.1980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-25 |
| Decision Date | 1997-01-23 |