The following data is part of a premarket notification filed by Applied Spectral Imaging, Ltd. with the FDA for Retinal Cube.
| Device ID | K973950 |
| 510k Number | K973950 |
| Device Name: | RETINAL CUBE |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | APPLIED SPECTRAL IMAGING, LTD. P.O. BOX 101 Migdal Haemek, IL 10551 |
| Contact | Michael Adel |
| Correspondent | Michael Adel APPLIED SPECTRAL IMAGING, LTD. P.O. BOX 101 Migdal Haemek, IL 10551 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-16 |
| Decision Date | 1997-12-12 |
| Summary: | summary |