510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K893744Substantially Equivalent

Smt-50A Magnetic Resonance Imaging System

Shimadzu Medical Systems, Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893744 is the FDA 510(k) clearance record for SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM, a class II device, cleared for Shimadzu Medical Systems on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list 90 510(k) clearances for Shimadzu Medical Systems, from to . As of , FDA records show no recalls naming K893744.

Clearance record

Decision date
Received
(172 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Shimadzu Medical Systems C/O Biometric Research Inst, Arlington VA
Third party review
No

Clearances, product code LNH

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