510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K240540Substantially Equivalent

uMR Omega

Shanghai United Imaging Healthcare Co., Ltd., Shanghai, CN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K240540 is the FDA 510(k) clearance record for uMR Omega, a class II device, cleared for Shanghai United Imaging Healthcare Co., Ltd. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list 84 510(k) clearances for Shanghai United Imaging Healthcare Co., Ltd., from to . As of , FDA records show no recalls naming K240540.

Clearance record

Decision date
Received
(25 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Shanghai United Imaging Healthcare Co., Ltd. #2258 Chengbei Rd. Jiading District, Shanghai, CN
510(k) summary
Summary PDF
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