The following data is part of a premarket notification filed by Visionary Systems, Inc. with the FDA for Act-1 (anterior Corneal Topographer).
| Device ID | K912740 |
| 510k Number | K912740 |
| Device Name: | ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) |
| Classification | Keratoscope, Ac-powered |
| Applicant | VISIONARY SYSTEMS, INC. 1810 NORTH NORTON AVE. Tucson, AZ 85719 |
| Contact | Steven R Lange |
| Correspondent | Steven R Lange VISIONARY SYSTEMS, INC. 1810 NORTH NORTON AVE. Tucson, AZ 85719 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-21 |
| Decision Date | 1991-12-30 |