510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123137Substantially Equivalent

Calypso System

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

K123137 is the FDA 510(k) clearance record for CALYPSO SYSTEM, a class II device, cleared for Varian Medical Systems on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 238 510(k) clearances for Varian Medical Systems, from to . As of , FDA records show no recalls naming K123137.

Clearance record

Decision date
Received
(61 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Varian Medical Systems 2101 Forth Ave., Suite 500, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYE

Trailing 12 months
15 clearances under product code IYE in the twelve months to November 2026, January 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code IYE, trailing twelve months
MonthClearances
December 20251
January 20264
February 20260
March 20261
April 20262
May 20261
June 20262
July 20260
August 20263
September 20261
October 20260
November 20260