The following data is part of a premarket notification filed by Sonomed, Inc. with the FDA for Axis Image Management System.
| Device ID | K171098 |
| 510k Number | K171098 |
| Device Name: | AXIS Image Management System |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Sonomed, Inc. 1979 Marcus Ave, Suite C105 New Hyde Park, NY 11042 |
| Contact | Mark Wallace |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-04-13 |
| Decision Date | 2017-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00896100002002 | K171098 | 000 |