The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Cytoguide.
| Device ID | K885020 |
| 510k Number | K885020 |
| Device Name: | CYTOGUIDE |
| Classification | System, X-ray, Mammographic |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | William G Mcmahon |
| Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-04-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CYTOGUIDE 79076289 3983427 Dead/Cancelled |
Cytoguide ApS 2009-09-18 |
![]() CYTOGUIDE 74247917 1769928 Live/Registered |
TURON MEDTECH AB 1992-02-20 |
![]() CYTOGUIDE 73490315 1377997 Dead/Cancelled |
THYREOS AB 1984-07-17 |