510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K092899Substantially Equivalent

Oper Series Open Type Permanent-Magnet MRI System, Model: Oper-0.3, -0.35, -0.4

Ningbo Xingaoyi Magnetism Co., Ltd., Yuyao, Zhejiang, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092899 is the FDA 510(k) clearance record for OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4, a class II device, cleared for Ningbo Xingaoyi Magnetism Co., Ltd. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list one 510(k) clearance for Ningbo Xingaoyi Magnetism Co., Ltd. As of , FDA records show no recalls naming K092899.

Clearance record

Decision date
Received
(50 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Ningbo Xingaoyi Magnetism Co., Ltd. East Tanjialing Rd., Yuyao, Zhejiang, CN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code LNH

Trailing 12 months
28 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 20263