The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Trans X 100 Chest Film Changer.
| Device ID | K900562 |
| 510k Number | K900562 |
| Device Name: | TRANS X 100 CHEST FILM CHANGER |
| Classification | System, X-ray, Stationary |
| 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 | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-07 |
| Decision Date | 1990-04-10 |