The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Scanview, Model Sc-300.
| Device ID | K071398 |
| 510k Number | K071398 |
| Device Name: | SCANVIEW, MODEL SC-300 |
| Classification | Device, Automated Cell-locating |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. HAMATECHET ST 4. Ramat Gavriel, IL 10551 |
| Contact | Silvia Stolarski |
| Correspondent | Silvia Stolarski APPLIED SPECTRAL IMAGING, LTD. HAMATECHET ST 4. Ramat Gavriel, IL 10551 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-21 |
| Decision Date | 2007-10-04 |
| Summary: | summary |