FDA 510(k)

HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM

K-Number: K024352 · 2003-01-09

Decision Date2003-01-09

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mri Devices Corp.. It received FDA 510(k) clearance on 2003-01-09 under 510(k) number K024352. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM?

HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2003-01-09. The listed applicant is Mri Devices Corp.. The 510(k) number is K024352.

When did HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM receive FDA 510(k) clearance?

HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM received FDA 510(k) clearance on 2003-01-09, under 510(k) number K024352.

Who is the listed applicant for HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM?

The FDA 510(k) record lists Mri Devices Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM?

The FDA product code for HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM is MOS.

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Other records listing Mri Devices Corp. as applicant

K041286DYNACAD V1.0 K041481MODEL BBC-127 BIOPSY BREAST COIL K040348MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL K040349MODIFICATION TO HRW-127 WRIST ARRAY COIL K040288QSC-127-INT SHOULDER ARRAY COIL SET K033447CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376

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Related Devices (Code: MOS)

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Official Source

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