FDA 510(k)

ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)

K-Number: K083086 · 2008-12-05

ApplicantHitachi Medical Systems America, Inc.

Decision Date2008-12-05

Product CodeMOS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K083086. 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 ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)?

ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K083086.

When did ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) receive FDA 510(k) clearance?

ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) received FDA 510(k) clearance on 2008-12-05, under 510(k) number K083086.

Who is the listed applicant for ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)?

The FDA 510(k) record lists Hitachi Medical Systems America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)?

The FDA product code for ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) is MOS.

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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.