FDA 510(k)

QUAD PELVIS COIL

K-Number: K943321 · 1994-09-23

ApplicantHitachi Medical Systems America, Inc.

Decision Date1994-09-23

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

QUAD PELVIS COIL 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 1994-09-23 under 510(k) number K943321. 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 QUAD PELVIS COIL?

QUAD PELVIS COIL is a medical device that received FDA 510(k) clearance on 1994-09-23. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K943321.

When did QUAD PELVIS COIL receive FDA 510(k) clearance?

QUAD PELVIS COIL received FDA 510(k) clearance on 1994-09-23, under 510(k) number K943321.

Who is the listed applicant for QUAD PELVIS COIL?

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 QUAD PELVIS COIL?

The FDA product code for QUAD PELVIS COIL 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.