The following data is part of a premarket notification filed by Leica Biosystems Imaging, Inc. with the FDA for Aperio Epathology Eihc Ivd System.
| Device ID | K141109 |
| 510k Number | K141109 |
| Device Name: | APERIO EPATHOLOGY EIHC IVD SYSTEM |
| Classification | Microscope, Automated, Image Analysis, Operator Intervention |
| Applicant | LEICA BIOSYSTEMS IMAGING, INC. 1360 PARK CENTER DRIVE Vista, CA 92081 |
| Contact | Christine Kishi |
| Correspondent | Christine Kishi LEICA BIOSYSTEMS IMAGING, INC. 1360 PARK CENTER DRIVE 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 | 2014-04-29 |
| Decision Date | 2014-07-29 |
| Summary: | summary |