The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Buckymatic Automatic Chest Film Changer.
| Device ID | K925598 |
| 510k Number | K925598 |
| Device Name: | BUCKYMATIC AUTOMATIC CHEST FILM CHANGER |
| Classification | Changer, Radiographic Film/cassette |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | James L Lambrecht |
| Correspondent | James L Lambrecht ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-05 |
| Decision Date | 1993-02-01 |