The following data is part of a premarket notification filed by Intelligent Medica Imaging, Inc. with the FDA for Ims-200.
| Device ID | K925670 |
| 510k Number | K925670 |
| Device Name: | IMS-200 |
| Classification | Device, Automated Cell-locating |
| Applicant | INTELLIGENT MEDICA IMAGING, INC. 4360 NORTHLAKE BOULEVARD, SUITE 108 Palm Beach Gardens, FL 33410 |
| Contact | Tyce Fitzmorris |
| Correspondent | Tyce Fitzmorris INTELLIGENT MEDICA IMAGING, INC. 4360 NORTHLAKE BOULEVARD, SUITE 108 Palm Beach Gardens, FL 33410 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-10 |
| Decision Date | 1993-07-23 |