The following data is part of a premarket notification filed by Chroma Vision Medical Systems Inc. with the FDA for Acis (automated Cellular Imaging System).
| Device ID | K032113 |
| 510k Number | K032113 |
| Device Name: | ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | CHROMA VISION MEDICAL SYSTEMS INC. 33171 PASEO CERVEZA San Juan Capistrano, CA 92675 |
| Contact | David Davis |
| Correspondent | David Davis CHROMA VISION MEDICAL SYSTEMS INC. 33171 PASEO CERVEZA San Juan Capistrano, CA 92675 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-09 |
| Decision Date | 2003-12-23 |
| Summary: | summary |