The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Scanview Her2/neu Fish System.
| Device ID | K101291 |
| 510k Number | K101291 |
| Device Name: | SCANVIEW HER2/NEU FISH SYSTEM |
| Classification | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. 6 SIRENI Haifa, IL 32972 |
| Contact | Dan Laor |
| Correspondent | Dan Laor APPLIED SPECTRAL IMAGING, LTD. 6 SIRENI Haifa, IL 32972 |
| Product Code | NTH |
| CFR Regulation Number | 866.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-07 |
| Decision Date | 2010-11-23 |
| Summary: | summary |