The following data is part of a premarket notification filed by Aperio Technologies with the FDA for Scanscope Xt System.
| Device ID | K080564 |
| 510k Number | K080564 |
| Device Name: | SCANSCOPE XT SYSTEM |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | APERIO TECHNOLOGIES 1360 PARK CENTER DR Vista, CA 92081 |
| Contact | Jeff Ryberg |
| Correspondent | Jeff Ryberg APERIO TECHNOLOGIES 1360 PARK CENTER DR Vista, CA 92081 |
| Product Code | NOT |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-28 |
| Decision Date | 2009-08-14 |
| Summary: | summary |