The following data is part of a premarket notification filed by Hitachi Healthcare Americas with the FDA for Optical Topography System Etg-4100.
| Device ID | K172492 |
| 510k Number | K172492 |
| Device Name: | Optical Topography System ETG-4100 |
| Classification | Oximeter |
| Applicant | Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Contact | Doug Thistlethwaite |
| Correspondent | Doug Thistlethwaite Hitachi Healthcare Americas 1959 Summit Commerce Park Twinsburg, OH 44087 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-17 |
| Decision Date | 2018-08-17 |
| Summary: | summary |