The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Genasis Scanview System.
| Device ID | K122554 |
| 510k Number | K122554 |
| Device Name: | GENASIS SCANVIEW SYSTEM |
| Classification | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. A-109 NETO- GOLF Caesarea, IL 30889 |
| Contact | Ilan Sharon |
| Correspondent | Ilan Sharon APPLIED SPECTRAL IMAGING, LTD. A-109 NETO- GOLF Caesarea, IL 30889 |
| Product Code | NTH |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-21 |
| Decision Date | 2013-02-07 |
| Summary: | summary |