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FDA 510(k)

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100

K-Number: K081935 · 2008-10-07

ApplicantAktina Medical Physics Corp.
Decision Date2008-10-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 is the device name listed in this FDA 510(k) record. The listed applicant is Aktina Medical Physics Corp.. It received FDA 510(k) clearance on 2008-10-07 under 510(k) number K081935. 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 STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100?

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 is a medical device that received FDA 510(k) clearance on 2008-10-07. The listed applicant is Aktina Medical Physics Corp.. The 510(k) number is K081935.

When did STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 receive FDA 510(k) clearance?

STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 received FDA 510(k) clearance on 2008-10-07, under 510(k) number K081935.

Who is the listed applicant for STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100?

The FDA 510(k) record lists Aktina Medical Physics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100?

The FDA product code for STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 is IYE.

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Other records listing Aktina Medical Physics Corp. 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.

K103616PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZERK040709PROTOS SOFTWAREK032248PRECISE CARBON FIBER TABLE TOP, MODEL 11-999K014081AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGESK003330AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)K993522AKTINA MEDICAL PHYSICS CORPORATION TENNIS RACQUET INSERT

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Related Devices (Code: 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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