FDA 510(k)

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T

K-Number: K082636 · 2008-09-25

Decision Date2008-09-25

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T is the device name listed in this FDA 510(k) record. The listed applicant is Quality Electrodynamics. It received FDA 510(k) clearance on 2008-09-25 under 510(k) number K082636. 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 TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T?

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Quality Electrodynamics. The 510(k) number is K082636.

When did TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T receive FDA 510(k) clearance?

TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T received FDA 510(k) clearance on 2008-09-25, under 510(k) number K082636.

Who is the listed applicant for TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T?

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

What is the FDA product code for TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T?

The FDA product code for TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T is MOS.

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Other records listing Quality Electrodynamics as applicant

K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)K233652Contour Hand/Wrist (Q7000232)K233656Contour Shoulder K122638TOSHIBA 3T 32CH HEAD SPEEDER COIL,K120627TOSHIBA 1.5T QD HEAD COIL K120290TOSHIBA 1.5T CARDIAC COIL

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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.