The following data is part of a premarket notification filed by Aperio Technologies with the FDA for Scanscope Xt System.
Device ID | K073677 |
510k Number | K073677 |
Device Name: | SCANSCOPE XT SYSTEM |
Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
Applicant | APERIO TECHNOLOGIES 1430 VANTAGE COURT, SUITE 106 Vista, CA 92081 |
Contact | Jeff Ryberg |
Correspondent | Jeff Ryberg APERIO TECHNOLOGIES 1430 VANTAGE COURT, SUITE 106 Vista, CA 92081 |
Product Code | NQN |
CFR Regulation Number | 864.1860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-28 |
Decision Date | 2008-08-01 |
Summary: | summary |