The following data is part of a premarket notification filed by Integrated Ophthalmic Systems, Inc. with the FDA for Continuum Pacs.
| Device ID | K200385 |
| 510k Number | K200385 |
| Device Name: | CONTINUUM PACS |
| Classification | System, Image Management, Ophthalmic |
| Applicant | Integrated Ophthalmic Systems, Inc. 596 Main Street Woburn, MA 01801 |
| Contact | Matthew Carnevale |
| Correspondent | Anna Reifschneider Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | NFJ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-03-16 |