The following data is part of a premarket notification filed by Quantel Medical with the FDA for Compact Touch Ophthalmic Ultrasound System.
| Device ID | K180265 |
| 510k Number | K180265 |
| Device Name: | COMPACT TOUCH Ophthalmic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Quantel Medical 11 Rue Bois Joli, CS40015 Cournon D'auvergne-cedex, FR 63808 |
| Contact | Maureen O'connell |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-01-31 |
| Decision Date | 2018-03-02 |
| Summary: | summary |