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FDA 510(k)

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY

K-Number: K981597 · 1998-10-09

ApplicantRadionics, Inc.
Decision Date1998-10-09
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1998-10-09 under 510(k) number K981597. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY?

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY is a medical device that received FDA 510(k) clearance on 1998-10-09. The listed applicant is Radionics, Inc.. The 510(k) number is K981597.

When did RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY receive FDA 510(k) clearance?

RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY received FDA 510(k) clearance on 1998-10-09, under 510(k) number K981597.

Who is the listed applicant for RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY?

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

What is the FDA product code for RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY?

The FDA product code for RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY is IYE.

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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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