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FDA 510(k)

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM

K-Number: K981346 · 1998-07-10

ApplicantSurgical Navigation Technologies, Inc.
Decision Date1998-07-10
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM 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 1998-07-10 under 510(k) number K981346. 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 BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM?

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-10. The listed applicant is Surgical Navigation Technologies, Inc.. The 510(k) number is K981346.

When did RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM receive FDA 510(k) clearance?

RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM received FDA 510(k) clearance on 1998-07-10, under 510(k) number K981346.

Who is the listed applicant for RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM?

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 BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM?

The FDA product code for RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM 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 SYSTEMK994355RADIOCAMERAS SYSTEM HEAD/NECK APPLICATIONK992461STEALTHSTATION TREATMENT GUIDANCE PLATFORMK992927STEALTHSTATION TREATMENT GUIDANCE PLATFORMK993021METRX SYSTEMK992354SNT IMAGE ANALYSIS SYSTEM

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Related Devices (Code: IYE)

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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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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