510(k) K252304

syngo.via RT Image Suite VC10 by Varian Medical Systems, Inc. — Product Code MUJ

K252304 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "syngo.via RT Image Suite VC10". The FDA issued a decision of Substantially Equivalent on March 18, 2026. The device falls under product code MUJ (System, Planning, Radiation Therapy Treatment), a Class II device regulated under 21 CFR 892.5050. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2026
Date Received
July 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Planning, Radiation Therapy Treatment
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type