The following data is part of a premarket notification filed by Computed Anatomy, Inc. with the FDA for Topographic Modeling System.
| Device ID | K901363 |
| 510k Number | K901363 |
| Device Name: | TOPOGRAPHIC MODELING SYSTEM |
| Classification | Keratoscope, Ac-powered |
| Applicant | COMPUTED ANATOMY, INC. 28 WEST 36TH ST. New York, NY 10018 |
| Contact | Martin Gersten |
| Correspondent | Martin Gersten COMPUTED ANATOMY, INC. 28 WEST 36TH ST. New York, NY 10018 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-23 |
| Decision Date | 1990-05-25 |