The following data is part of a premarket notification filed by Tomey Corporation Usa with the FDA for Imagescape Digital Retinal Image System.
| Device ID | K971685 |
| 510k Number | K971685 |
| Device Name: | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | TOMEY CORPORATION USA 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein TOMEY CORPORATION USA 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-07 |
| Decision Date | 1997-06-24 |
| Summary: | summary |