510(k) K250299

CT/ MR Tandem and Ovoid Set by Varian Medical Systems, Inc. — Product Code JAQ

K250299 is an FDA 510(k) premarket notification submitted by Varian Medical Systems, Inc. for the device "CT/ MR Tandem and Ovoid Set". The FDA issued a decision of Substantially Equivalent on May 9, 2025. The device falls under product code JAQ (System, Applicator, Radionuclide, Remote-Controlled), a Class II device regulated under 21 CFR 892.5700. Varian Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 2025
Date Received
January 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Applicator, Radionuclide, Remote-Controlled
Device Class
Class II
Regulation Number
892.5700
Review Panel
RA
Submission Type