510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945155Substantially Equivalent

Airis

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

K945155 is the FDA 510(k) clearance record for AIRIS, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show 3 recalls naming K945155.

Clearance record

Decision date
Received
(215 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Hitachi Medical Systems America, Inc. 1963 Case Pkwy., Twinsburg OH
510(k) summary
Summary
Third party review
No

Clearances, product code LNH

Trailing 12 months
25 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20260