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FDA 510(k)

FAST SPIN ECHO

K-Number: K935664 · 1994-03-16

ApplicantHitachi Medical Systems America, Inc.
Decision Date1994-03-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FAST SPIN ECHO 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 1994-03-16 under 510(k) number K935664. 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 FAST SPIN ECHO?

FAST SPIN ECHO is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K935664.

When did FAST SPIN ECHO receive FDA 510(k) clearance?

FAST SPIN ECHO received FDA 510(k) clearance on 1994-03-16, under 510(k) number K935664.

Who is the listed applicant for FAST SPIN ECHO?

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 FAST SPIN ECHO?

The FDA product code for FAST SPIN ECHO is LNH.

Other records listing Hitachi Medical Systems America, Inc. as applicant

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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.

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