510(k) K240822

Image Management V15 by Philips Medical Systems Technologies — Product Code LLZ

K240822 is an FDA 510(k) premarket notification submitted by Philips Medical Systems Technologies for the device "Image Management V15". The FDA issued a decision of Substantially Equivalent on April 24, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050. Philips Medical Systems Technologies has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2024
Date Received
March 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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