510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853754Substantially Equivalent

Magnetic Resonance Imaging Uniformity/t1 76-901

Victoreen, Inc., Carle Place NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853754 is the FDA 510(k) clearance record for MAGNETIC RESONANCE IMAGING UNIFORMITY/T1 76-901, a class I device, cleared for Victoreen, Inc. on under FDA product code LHO (Instrument, Quality-Assurance, Radiologic). FDA records list 40 510(k) clearances for Victoreen, Inc., from to . As of , FDA records show no recalls naming K853754.

Clearance record

Decision date
Received
(240 days to decision)
Product code
LHO Instrument, Quality-Assurance, Radiologic
Regulation
21 CFR 892.1940
Device class
Class I
Review panel
Radiology
Applicant
Victoreen, Inc. 100 Voice Rd., Carle Place NY
Third party review
No

Clearances, product code LHO

Trailing 12 months

FDA records hold no clearances under product code LHO in the trailing twelve months.

FDA records show no clearances under product code LHO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LHO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260