510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K953391Substantially Equivalent

Treatment Management System

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

K953391 is the FDA 510(k) clearance record for TREATMENT MANAGEMENT SYSTEM, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K953391.

Clearance record

Decision date
Received
(232 days to decision)
Product code
LHN System, Radiation Therapy, Charged-Particle, Medical
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Siemens Medical Solutions USA, Inc. 4040 Nelson Ave., Concord CA
510(k) summary
Summary
Third party review
No

Clearances, product code LHN

Trailing 12 months
4 clearances under product code LHN in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LHN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260
November 20260