The following data is part of a premarket notification filed by Leica Biosystems Imaging, Inc. with the FDA for Aperio At2 Dx System.
| Device ID | K190332 |
| 510k Number | K190332 |
| Device Name: | Aperio AT2 DX System |
| Classification | Whole Slide Imaging System |
| Applicant | Leica Biosystems Imaging, Inc. 1360 Park Center Dr. Vista, CA 92081 |
| Contact | Christine Kishi |
| Correspondent | Christine Kishi Leica Biosystems Imaging, Inc. 1360 Park Center Dr. Vista, CA 92081 |
| Product Code | PSY |
| CFR Regulation Number | 864.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815477020259 | K190332 | 000 |