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FDA 510(k)

OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4

K-Number: K092899 · 2009-11-10

ApplicantNingbo Xingaoyi Magnetism Co., Ltd.
Decision Date2009-11-10
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Xingaoyi Magnetism Co., Ltd.. It received FDA 510(k) clearance on 2009-11-10 under 510(k) number K092899. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4?

OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 is a medical device that received FDA 510(k) clearance on 2009-11-10. The listed applicant is Ningbo Xingaoyi Magnetism Co., Ltd.. The 510(k) number is K092899.

When did OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 receive FDA 510(k) clearance?

OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 received FDA 510(k) clearance on 2009-11-10, under 510(k) number K092899.

Who is the listed applicant for OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4?

The FDA 510(k) record lists Ningbo Xingaoyi Magnetism Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4?

The FDA product code for OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 is LNH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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