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FDA 510(k)

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL

K-Number: K991237 · 1999-08-30

ApplicantRadionics, Inc.
Decision Date1999-08-30
Product CodeMUJ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, Inc.. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K991237. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL?

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Radionics, Inc.. The 510(k) number is K991237.

When did XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL receive FDA 510(k) clearance?

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL received FDA 510(k) clearance on 1999-08-30, under 510(k) number K991237.

Who is the listed applicant for XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL?

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 XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL?

The FDA product code for XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL is MUJ.

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Other records listing Radionics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MUJ)

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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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