The following data is part of a premarket notification filed by Chromavision Medical Systems, Inc. with the FDA for Automated Cellular Imaging System (acis).
| Device ID | K984188 |
| 510k Number | K984188 |
| Device Name: | AUTOMATED CELLULAR IMAGING SYSTEM (ACIS) |
| Classification | Device, Automated Cell-locating |
| Applicant | CHROMAVISION MEDICAL SYSTEMS, INC. 3535 FIREWHEEL DR. SUITE A Flower Mound, TX 75028 -2628 |
| Contact | Bertram J Hudson |
| Correspondent | Bertram J Hudson CHROMAVISION MEDICAL SYSTEMS, INC. 3535 FIREWHEEL DR. SUITE A Flower Mound, TX 75028 -2628 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-07-28 |
| Summary: | summary |