FDA 510(k)

TORSO ARRAY COIL, MODEL 558GE-64

K-Number: K041185 · 2004-05-14

Decision Date2004-05-14

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TORSO ARRAY COIL, MODEL 558GE-64 is the device name listed in this FDA 510(k) record. The listed applicant is Igc-Medical Advances, Inc.. It received FDA 510(k) clearance on 2004-05-14 under 510(k) number K041185. 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 TORSO ARRAY COIL, MODEL 558GE-64?

TORSO ARRAY COIL, MODEL 558GE-64 is a medical device that received FDA 510(k) clearance on 2004-05-14. The listed applicant is Igc-Medical Advances, Inc.. The 510(k) number is K041185.

When did TORSO ARRAY COIL, MODEL 558GE-64 receive FDA 510(k) clearance?

TORSO ARRAY COIL, MODEL 558GE-64 received FDA 510(k) clearance on 2004-05-14, under 510(k) number K041185.

Who is the listed applicant for TORSO ARRAY COIL, MODEL 558GE-64?

The FDA 510(k) record lists Igc-Medical Advances, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TORSO ARRAY COIL, MODEL 558GE-64?

The FDA product code for TORSO ARRAY COIL, MODEL 558GE-64 is MOS.

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Other records listing Igc-Medical Advances, Inc. as applicant

K040640MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL K033292AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12 K023848MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:K003366MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL K001312MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL K000589MODEL 445SI-64E QUADRATURE WRIST COIL

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Related Devices (Code: MOS)

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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.