510(k) K250181

AV Viewer by Philips Medical Systems Nederland B.V. — Product Code LLZ

K250181 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Nederland B.V. for the device "AV Viewer". The FDA issued a decision of Substantially Equivalent on July 15, 2025. 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 at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2025
Date Received
January 22, 2025
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