510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093044Substantially Equivalent

Oasis MRI System

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093044 is the FDA 510(k) clearance record for OASIS MRI SYSTEM, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code LNI (System, Nuclear Magnetic Resonance Spectroscopic). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show one recall naming K093044.

Clearance record

Decision date
Received
(167 days to decision)
Product code
LNI System, Nuclear Magnetic Resonance Spectroscopic
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LNI

Trailing 12 months

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

FDA records show no clearances under product code LNI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LNI, 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