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FDA 510(k)

STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE

K-Number: K827583 · 1982-09-29

ApplicantNucletronix, Inc.
Decision Date1982-09-29
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Nucletronix, Inc.. It received FDA 510(k) clearance on 1982-09-29 under 510(k) number K827583. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE?

STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE is a medical device that received FDA 510(k) clearance on 1982-09-29. The listed applicant is Nucletronix, Inc.. The 510(k) number is K827583.

When did STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE receive FDA 510(k) clearance?

STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE received FDA 510(k) clearance on 1982-09-29, under 510(k) number K827583.

Who is the listed applicant for STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE?

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

What is the FDA product code for STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE?

The FDA product code for STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE is IWB.

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Related Devices (Code: IWB)

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.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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