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FDA 510(k)

XPLAN-1

K-Number: K972905 · 1997-10-28

ApplicantRadionics Software Applications, Inc.
Decision Date1997-10-28
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLAN-1 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1997-10-28 under 510(k) number K972905. 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 XPLAN-1?

XPLAN-1 is a medical device that received FDA 510(k) clearance on 1997-10-28. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K972905.

When did XPLAN-1 receive FDA 510(k) clearance?

XPLAN-1 received FDA 510(k) clearance on 1997-10-28, under 510(k) number K972905.

Who is the listed applicant for XPLAN-1?

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

What is the FDA product code for XPLAN-1?

The FDA product code for XPLAN-1 is IYE.

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Other records listing Radionics Software Applications, 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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