The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Multi-modality Tumor Tracking (mmtt) Application.
Device ID | K162955 |
510k Number | K162955 |
Device Name: | Multi-Modality Tumor Tracking (MMTT) Application |
Classification | System, Image Processing, Radiological |
Applicant | Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best Best Noord-brabant, NL 5684 Pc |
Contact | Yoram Levy |
Correspondent | Yoram Levy Qsite 31 Haavoda St. Binyamina, IL 30500 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-24 |
Decision Date | 2016-12-19 |
Summary: | summary |