510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973960Substantially Equivalent

Model 37-185

Victoreen, Inc., Solon OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973960 is the FDA 510(k) clearance record for MODEL 37-185, a class II device, cleared for Victoreen, Inc. on under FDA product code LHN (System, Radiation Therapy, Charged-Particle, Medical). FDA records list 40 510(k) clearances for Victoreen, Inc., from to . As of , FDA records show no recalls naming K973960.

Clearance record

Decision date
Received
(90 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
Victoreen, Inc. 6000 Cochran Rd., Solon OH
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 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