The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Cts System.
| Device ID | K941004 |
| 510k Number | K941004 |
| Device Name: | CTS SYSTEM |
| Classification | Tube Mount, X-ray, Diagnostic |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Jame Lambrecht |
| Correspondent | Jame Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | IYB |
| CFR Regulation Number | 892.1770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-01 |
| Decision Date | 1994-07-29 |