The following data is part of a premarket notification filed by Applied Imaging Corp. with the FDA for Winscan Automated Imaging System.
| Device ID | K980375 |
| 510k Number | K980375 |
| Device Name: | WINSCAN AUTOMATED IMAGING SYSTEM |
| Classification | Device, Automated Cell-locating |
| Applicant | APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Contact | Patricia A Milbank |
| Correspondent | Patricia A Milbank APPLIED IMAGING CORP. 2380 WALSH AVE., BLDG.B Santa Clara, CA 95051 |
| Product Code | JOY |
| CFR Regulation Number | 864.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-06-09 |
| Summary: | summary |