510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K032886Substantially Equivalent

Diamond Setup 2000

K&S Assoc., Inc., Nashville TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032886 is the FDA 510(k) clearance record for DIAMOND SETUP 2000, a class II device, cleared for K&S Assoc., Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list one 510(k) clearance for K&S Assoc., Inc. As of , FDA records show no recalls naming K032886.

Clearance record

Decision date
Received
(115 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
K&S Assoc., Inc. 1926 Elm Tree Dr., Nashville TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LHN

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