The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Philips Herceptest Digital Score.
| Device ID | K130021 |
| 510k Number | K130021 |
| Device Name: | PHILIPS HERCEPTEST DIGITAL SCORE |
| Classification | Automated Digital Image Manual Interpretation Microscope |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, Nb, NL 5684 Pc |
| Contact | Dirk Vossen |
| Correspondent | Dirk Vossen PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, Nb, NL 5684 Pc |
| Product Code | OEO |
| CFR Regulation Number | 864.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-03 |
| Decision Date | 2013-09-19 |
| Summary: | summary |