The following data is part of a premarket notification filed by Bioimagene, Inc. with the FDA for Pathiam System With Iscan For P53 And Ki-67.
| Device ID | K092333 |
| 510k Number | K092333 |
| Device Name: | PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 |
| Classification | Microscope, Automated, Image Analysis, Immunohistochemistry,operator Intervention,nuclear Intensity & Percent Positivity |
| Applicant | BIOIMAGENE, INC. 919 HERMOSA CT. Sunnyvale, CA 94085 |
| Contact | Indu P Lakshman |
| Correspondent | Indu P Lakshman BIOIMAGENE, INC. 919 HERMOSA CT. Sunnyvale, CA 94085 |
| Product Code | NQN |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-04 |
| Decision Date | 2010-10-27 |
| Summary: | summary |