The following data is part of a premarket notification filed by Acoma Medical Imaging, Inc. with the FDA for Model Esp-200 Mammographic System.
| Device ID | K884345 |
| 510k Number | K884345 |
| Device Name: | MODEL ESP-200 MAMMOGRAPHIC SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Contact | John W Lee |
| Correspondent | John W Lee ACOMA MEDICAL IMAGING, INC. 150 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-14 |
| Decision Date | 1989-03-23 |