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FDA 510(k)

RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION

K-Number: K994355 · 2000-03-22

ApplicantSurgical Navigation Technologies, Inc.
Decision Date2000-03-22
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Navigation Technologies, Inc.. It received FDA 510(k) clearance on 2000-03-22 under 510(k) number K994355. 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 RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION?

RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION is a medical device that received FDA 510(k) clearance on 2000-03-22. The listed applicant is Surgical Navigation Technologies, Inc.. The 510(k) number is K994355.

When did RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION receive FDA 510(k) clearance?

RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION received FDA 510(k) clearance on 2000-03-22, under 510(k) number K994355.

Who is the listed applicant for RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION?

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

What is the FDA product code for RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION?

The FDA product code for RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION is IYE.

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Other records listing Surgical Navigation Technologies, 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.

K000246RADIOCAMERAS EXTRACRANIAL SYSTEMK992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMK993021METRX SYSTEMK992354SNT IMAGE ANALYSIS SYSTEMK991468IMMERGE IMAGE CORRELATION

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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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