510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K030745Substantially Equivalent

Gammamed 212 and 232 Source Assembly

Varian Medical Systems, Inc., Charlottesville VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030745 is the FDA 510(k) clearance record for GAMMAMED 212 AND 232 SOURCE ASSEMBLY, a class II device, cleared for Varian Medical Systems on under FDA product code KXK (Source, Brachytherapy, Radionuclide). FDA records list 238 510(k) clearances for Varian Medical Systems, from to . As of , FDA records show no recalls naming K030745.

Clearance record

Decision date
Received
(2 days to decision)
Product code
KXK Source, Brachytherapy, Radionuclide
Regulation
21 CFR 892.5730
Device class
Class II
Review panel
Radiology
Applicant
Varian Medical Systems 700 Harris St., Charlottesville VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KXK

Trailing 12 months
1 clearance under product code KXK in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KXK, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260