510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K132935Substantially Equivalent

Artiste Solution with Sys_vc10c and Syngo Rt Therapist Workspace, V4.3.1 Upgrade Kit, Aria Connectivity Option for Sieme

Siemens Medical Solutions USA, Inc., Martinez CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132935 is the FDA 510(k) clearance record for ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code IYE (Accelerator, Linear, Medical). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K132935.

Clearance record

Decision date
Received
(156 days to decision)
Product code
IYE Accelerator, Linear, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 757 A Arnold Dr., Martinez CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IYE

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