510(k) K173467

Advanced Diffusion Analysis (ADA) application by Philips Medical Systems Nederland B.V. — Product Code LLZ

K173467 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "Advanced Diffusion Analysis (ADA) application". The FDA issued a decision of Substantially Equivalent on Dec 12, 2017. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Philips Medical Systems Nederland B.V. has 106 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 12, 2017
Date Received
Nov 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type
510(k)