The following data is part of a premarket notification filed by Ikonisys Inc with the FDA for Ikoniscope Fastfish Amnio Imaging System.
| Device ID | K052577 |
| 510k Number | K052577 |
| Device Name: | IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | IKONISYS INC 5 SCIENCE PARK SUITE 1000 New Haven, CT 06511 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp IKONISYS INC 5 SCIENCE PARK SUITE 1000 New Haven, CT 06511 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2006-01-24 |
| Summary: | summary |